Wednesday, December 31, 2008

2009 Pharmaceutical Trends

Wishing all of you a Happy New Year! If you're starting to look ahead to the new year, read this analysis of the economic forecast for pharma in this MSN Money post, "IMS Health Forecasts 4.5 - 5.5 Percent Growth for Global Pharmaceutical Market in 2009, Exceeding $820 Billion." In this 2009 forecast, IMS identifies the following key market dynamics . . .

  • Slowing Growth in Mature Markets
  • Rapid Expansion of “Pharmerging” Markets
  • An Emphasis on Specialist-Driven Markets
  • Fewer Products Winning Regulatory Approval
  • An Economic Slowdown, Most Pronounced in the US
  • Generics Market Continues to Evolve
  • Intensified Involvement of Payers and Health Technology Assessors

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Tuesday, December 30, 2008

2009 - Top 10 Trends For The Medical Equipment Market

Updated July 21, 2017

The link in the original post below didn't age well.

You might also be interested in:
DURABLE MEDICAL EQUIPMENT - MARKET UPDATE - MARCH 2016 (Harris Williams PDF)


- - original post follows below  - -

Another year year has gone by, and it was a tough one at that. Wishing you the best this coming 2009. As a preview of what's to come, read this excellent analysis by the folks at Reports-Research.com, "Top 10 Medical Equipment Market Trends For 2009." If you don't have time to read this detailed post, here are the high points . . .
  1. Obama Plans To Bring Stellar Growth For Healthcare Information Technology
  2. Home Healthcare Equipment Market Is Poised For A Big Return In 2009 Owing To Cost Containment Efforts By Both Providers And Purchasers
  3. Emerging Medical Equipment Markets Will Continue To Grow In 2009, Assisted By The Ongoing Trend Towards Medical Tourism And Helping To Offset Any Negative Impact Felt By The General Economic Downturn
  4. Major Medical Equipment Manufacturers To Remain Stable In Spite Of Mounting Financial Crisis
  5. Direct To Consumer Advertising Of Medical Devices To Continue To Increase In Prominence In 2009
  6. Healthcare Information Technology Spend To Gain Significant Attention In 2009 And Beyond From Both Developed And Emerging Economies
  7. Drug Eluting Stents On A Comeback Trail In The US Market
  8. In 2009Young Adults And Middle Aged Patients To Drive The US Market For Hip Resurfacing For Next Five Years
  9. Cash Rich And Innovative Companies To Benefit In The Current Economic Scenario
  10. Products Related To Women’s Health, Minimally Invasive Surgery And Home Healthcare Are Set To Garner Special Attention In 2009
  11. High Volume And Low Value Of Deals Will Be A Norm In The Medical Equipment Mergers And Acquisitions Landscape In 2009

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Monday, December 29, 2008

FDA - Global Drug Supply Chain Needs Better Oversight

We're still reeling from the tainted heparin situation, and I suspect that it's only the tip of the iceberg. A rising percentage of drugs are coming from China and India, reports this ASHP News article, "World's Drug Supply Chain Needs Better Oversight, FDA Says." The associate commissioner for policy and planning at FDA is quoted, and here's a small sample of highlights . . .

  • "where there are economic incentives and/or there is lax regulatory oversight, there is going to be greater opportunity for risky or criminal behavior"
  • "If we have good behavior, we want to facilitate compliance. If we have risky behavior, we want to provide deterrence. And with criminal behavior, we need rapid detection and aggressive enforcement. And electronic track and trace can play an important role in it."

Previous Posts:
CA E-Pedigree - Pedigree and Serialization
Gambling With Life - Counterfeit Drugs - Like ED Drugs (Viagra)
Counterfeiters Can Get Life In Jail

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Sunday, December 28, 2008

Get In Shape In 2009 - Trying one of these 20 fitness trends?

The holidays are almost over. Are you going to try and follow one of these top fitness trends in 2009, reported by MedicineNet, "American College of Sports Medicine Survey Predicts Next Year's Fitness Trends." Here's the what the professionals think will be hot in the coming year . . .

  1. Educated and experienced fitness professionals
  2. Children and obesity
  3. Personal training
  4. Strength training
  5. Core training
  6. Special fitness programs for older adults
  7. Pilates
  8. Stability ball
  9. Sport-specific training
  10. Balance training
  11. Functional fitness
  12. Comprehensive health programming at work
  13. Wellness coaching
  14. Worker incentive programs
  15. Outcome measurements
  16. Spinning (indoor cycling)
  17. Physician referrals
  18. Exercise and weight loss
  19. Group personal training
  20. Reaching new markets

Do you have a workout plan for 2009?

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Saturday, December 27, 2008

Serious Drug Interaction Risks For Older Adults (video)

If you are, or know an older adult, taking medications, then you should read this. Researchers from the University of Chicago Medical Center report that at least one in 25 older adults, about 2.2 million people in the United States, take multiple drugs in combinations that can produce a harmful drug-drug interaction, and half of these interactions involve a non-prescription medication. This WRAL.com video gives you the major highlights, "Mixing medications poses risks (video)."

For further reading on the subject:

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Friday, December 26, 2008

FDA Warning On Weight Loss Products


No doubt we'll have overeaten on Christmas, and we'll continue to do so through the holidays. Then in the new year, we'll all be tempted to lose some weight. We'll schedule workouts at the gym, go on diets, and start taking weight loss products. But stop and read before you take those weight loss products, warns the FDA, as reported in a recent American Society of Health-System Pharmacists (ASHP) daily news briefing. In general, the FDA "has listed more than 25 weight loss products to avoid, because they contain ingredients that are not labeled, and could cause serious health problems." Some of the ingredients illegally contain drugs that should be sold by prescription only. The news briefing suggests the following links for further reading . . .

Are you planning to take weight loss pills?

Bloomberg News - Illegal Weight Loss Pills May Cause Heart Attacks

FDA News - FDA Warns Consumers About Tainted Weight Loss Pills

AP News - FDA warns against some diet pills sold on the Web

HealthDay - FDA Warns About Weight Loss Products

Chicago Tribune - FDA warnings for 30 diet drugs

WebMD - FDA Warns of Risky Weight Loss Pills

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Thursday, December 25, 2008

Interesting FDA History - CFR for white chocolate

Updated October 3, 2016

Some of the links in the original post below have broken.

You might also be interested in:
Guidance for Industry: Standard of Identity for White Chocolate - FDA

- -  original past follows below  - -

This is something fun to read on Christmas day. Many years ago, chocolate manufacturers had to fight for the ability to use the term "white chocolate," as this Chocolate.com article recounts, "White Chocolate FDA Standard." If you didn't already know, the FDA has very specific specifications for what qualifies as white chocolate, "PART 163 -- CACAO PRODUCTS -
Subpart B--Requirements for Specific Standardized Cacao Products - Sec. 163.124 White chocolate.

Merry Christmas!

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Wednesday, December 24, 2008

FDA QSR Human Factors Reqs - Intro

OK, now I get it. I understand this topic quite a bit better after reading Human Factors MD's "FDA Human Factors Requirements." This is applicable for medical devices that need to follow the FDA's regulations on Do It By Design: An Introduction to Human Factors in Medical Devices and Medical Device Use-Safety: Incorporating Human Factors Engineering into Risk Management. Even better, the folks at Human Factor's MD, cite section 820.30 of the QSR, in paragraphs c, f, and g, and walk us through the meaning and application of those paragraphs. Did you find it helpful too? These three paragraphs cover . . .

  • design input
  • design verification
  • design validation

Additional Resources & Previous Posts:
The FDA's Human Factors Program (promoting safety in medical device use)
6 Free FDA QSR Design Controls Tutorials
FDA CDRH Online Courses (Free)
Free 21 CFR Part 820 QSR Audit Checklist

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Tuesday, December 23, 2008

Cross-Reference GLPs by FDA EPA and OECD (free)


If you ever had an interest or need to compare the GLPs (Good Laboratory Practices) across these three organizations, then you need to look at the FDA's "Comparison Chart of FDA and EPA Good Laboratory Practice (GLP) Regulations and the OECD Principles of GLP." The information is organized in tables that cross-walk and cross-reference a particular row topic against the three columns for each organization. Here's what you'll be able to see . . .

Preface
Scope and Authority
Definitions
Organization and Personnel
Facilities
Equipment
Facility Operation
Articles
Protocol and Conduct
Records and Reports
Disqualification

Glossary:
GLP = Good Laboratory Practice
FDA = Food and Drug Administration
EPA = Environmental Protection Agency
OECD = Organisation for Economic Co-operation and Development

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Monday, December 22, 2008

FDA - FAQs About Combination Products

If you're just getting into the regulations that govern combination products, or need a quick refresher, then check out this collection of FDA Frequently Asked Questions about combination products, published by the FDA. Here's a quick list of what you'll find . . .


General
What is a combination product?
What are some examples of combination products?
What are the roles of the Office of Combination Products?
What staff members comprise the Office of Combination Products, and who can I contact for specific issues?
I have some questions about how a combination product will be regulated. What information will help OCP understand my product so they may respond to my inquiry?
How can I contact OCP?
Where can I find out about workshops and public meetings on combination products?
How can I get copies of slides from OCP presentations?
What has OCP accomplished so far, and what is the Office currently working on?
Product Jurisdiction/Assignment of Combination and Non-Combination Products
How are combination products assigned for review?
How do I determine which Center will review my combination or non-combination product?
How do I submit a Request for Designation for a combination or non-combination product?
How promptly will my RFD be reviewed?
Premarket Review and Postmarket Regulation of Combination Products
What investigational application should I use for a combination product?
What types of marketing applications are required for a combination product?
Does OCP review marketing applications for combination products?
What format should I use to submit a marketing application for a combination product?
What is the difference between consultative and collaborative reviews of combination products?
How do I request that OCP or review staff from a consulting Center attend a regulatory meeting, such as a pre-IDE or pre-IND meeting, with agency reviewers?
What good manufacturing practice regulations apply to combination products?
How are adverse events reported for combination products?
Where can I get information about user fees for combination products?
Where can I find guidance for what kind of safety and effectiveness information is needed to support approval of a combination product?
Where can I find guidance for how master files can be used in the submission of information relevant to my combination product?
We have developed a new combination product and would like to initiate a dialogue with the appropriate FDA staff to obtain guidance on how to go about obtaining approval. However, we have limited experience in dealing with the FDA and do not know whom we should contact. Can the Office of Combination Products help?
How do I submit a formal request that OCP resolve a dispute regarding the timeliness of premarket review of a combination product?
The Medical Device User Fee and Modernization Act (MDUFMA) requires FDA to report annually on the numbers and types of combination products reviewed, and the timeliness of such reviews. Where can I find these data, and how does FDA determine the types of combination products?
Other Issues
How are products that combine two or more drugs regulated?
How are products that combine a drug and a cosmetic regulated?
How are products that combine a drug and a dietary supplement regulated?
Where can I find information about novel drug delivery systems?
Where can I find information about in vitro diagnostic tests used in pharmacogenomics?
I believe my combination product may qualify for designation as an orphan drug or biological product, or as a humanitarian use device. Where can I find information about orphan product regulation?
Where can I find more information about the regulation of nanotechnology products, including combination products involving nanotechnology?

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Sunday, December 21, 2008

Australian Wine Doctor Says Drink His Wine For Health

Wine contains a substance called resveratrol. It's reported to offer some health benefits by cleaning blood vessels and to reduce the risk of heart attacks and stroke. Dr. Norrie talks about the wine he makes, that contains much more of the substance than most other wines, in this MSNBC News video, "Bottoms up for a healthy heart."

A word of caution, the purported health benefits in people are yet to be definitively proven.

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Saturday, December 20, 2008

iBreath - A Breathalyzer For Your iPod or iPhone

Way cool! Now you can connect an alcohol breathalyzer to your iPod or iPhone, reports this LA Times news article, "Blow into the iBreath and your iPod plays a blood-alcohol alert. Measure your blood alcohol level, and avoid driving while you're drunk. For about $80, you buy the iBreath from David Steele.com. How would you use the iBreath?

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And The Top 10 Food Stories Of 2008

. . . according to QSR Magazine's article, "The Top 10 Food Stories of 2008," include some concerning food safety items. If you're in the food chain supply, or are just interested as a consumer, here's the quick list of the stories . . .

  1. The rise in food prices around the world
  2. China's tainted milk scandal
  3. The salmonella outbreak in raw tomatoes
  4. Supermarket Chains Offer More Locally Grown Food
  5. New USDA Labeling Laws
  6. Big Food Companies Adopt Nutrient Standards
  7. Jalapeno Peppers Test Positive for Salmonella
  8. Paul Newman Dies
  9. NYC Restaurant Trans Fat Regulations
  10. New Levels of Alarm Associated With High Salt Intake

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Friday, December 19, 2008

Sugar As Addictive As Cocaine Or Heroin

Recent research suggests this might be true, reports this NY Daily News article, "Sugar as addictive as cocaine, heroin, studies suggest." Princeton University researchers studied bingeing and dependency in rats and found these startling results. Here's just a few of their findings . . .

  • rat brains undergo changes similar to the changes in the brains of people who abuse illegal drugs like cocaine and heroin
  • rats showed behavioral changes, including signs of withdrawal and long-lasting effects that resemble cravings
  • when sugar was taken away, the rats showed signs of withdrawal, like symptoms seen in people when they stop smoking, drinking alcohol, or using drugs

I follow the Atkins diet as an approach to eating (not for active dieting purposes), and I find that my occasional binges of sugar really make me feel differently. Have you experienced anything like what's described above?

Previous Posts:
September is National Alcohol and Drug Addiction Recovery Month

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Thursday, December 18, 2008

GLP Training Tips (free)

If you're responsible for delivering GLP training, then read this helpful article, "A Summary of Glp Training Regulation Requirements in 21 Cfr Part 58: Associated Complications and Solutions." It's important to think about some of the solutions and associated ramifications for the training approach you're going to choose.

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Wednesday, December 17, 2008

FDA Alert - Bowel Cleanser Warning

This is something you should read if you do 'cleanses' or are preparing for GI (gastrointestinal) or a colonoscopy procedure. Many of these related products can be found everywhere, including the corner drug store, so be aware. Read this FDA news release for the full details, "FDA Requires New Safety Measures for Oral Sodium Phosphate Products to Reduce Risk of Acute Kidney Injury Risk associated with both prescription and over-the-counter (OTC) products. The greatests risk are associated with . . .

  • people over 55 years of age,
  • people who suffer from dehydration, kidney disease, acute colitis, or delayed bowel emptying, and
  • people taking certain medicines that affect kidney function, such as diuretics (fluid pills), angiotensin converting enzyme inhibitors (medications that lower blood pressure) angiotensin receptor blockers, (used to treat high blood pressure, heart or kidney failure) and possibly nonsteroidal anti-inflammatory drugs (similar to ibuprofen and other arthritis medications).
  • FDA also warns that products should not be used by children under 18 years of age or in combination with other laxative products containing sodium phosphate

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Tuesday, December 16, 2008

Free FDA Good Laboratory Practice Tutorial - GLP

Free FDA GLP Tutorial


Check out this fantastic free tutorial by the folks at LabCompliance, "Good Laboratory Practice Regulations." It's a great introduction and primer on the FDA's GLPs (Good Laboratory Practice).

At the time of this post, the tutorial is free. Be forewarned that the vendor initially makes their tutorials accessible to all visitors of LabCompliance at no charge. However over time they are moved to the Usersclub section and hence accessible to Club Members. I'm telling you this just in case you're reading this post and discover that the tutorial is no longer freely accessible.

You might also be interested in:
ISO 17025: Calibration Laboratories - cGMP training by SkillsPlus Intl Inc.

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Monday, December 15, 2008

The FDA On Combination Products (drug-biologic with medical device)

It's hard enough to comply with a single set of regulations. Now it's even harder, if you manufacture a combination product (which has a drug/biologic component and a medical device component). That's because a larger set of rules and regulations have to be followed, says this PharmTech Talk article, "Combo Products Come with More Regs." Bottomline, you can expect an increase in "GMP regulatory action along both the laboratory and manufacturing lines."

Previous Posts:
Nice Review of US FDA Medical Device Regulation
Medical Devices Containing Antimicrobial Agents - FDA Guidance Pending
FDA Guidance Documents - FDA Current Thinking (free)

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Sunday, December 14, 2008

Yes - We Pop Way Too Many Pills (video)

Do you think we pop too many pills? It's my impression that we do. Just watch this MSNBC News video, "Are we popping too many pills." As the video says, it might be because we all want immediate treatment, and that pills can solve every problem.

What do you think?

Previous Posts:
Are We Weaker Vessels? - Seniors make more MD visits than 10 yrs ago

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Saturday, December 13, 2008

Epidemic Teen Addiction To Prescription Drugs (video)


It's shocking! Teens are finding it easier to obtain prescription drugs than alcohol, reports this MSNBC News Video, "Teens abusing prescription drugs." It turns out that the internet is a great teacher and source for obtaining prescription drugs without a prescription. I find this a very provocative video. What do you think?

Previous Posts:
Parents, Get A Clue About Teen Drug and Alcohol Abuse

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Friday, December 12, 2008

Eccch - Read This Before Touching That Grocery Cart

Ever wonder what's on that grocery store cart? . . . how about zillions of bacteria! Read this scary article by KSWO, and see why you should care, "Special Report: "Clean Those Carts"." Some take-home messages . . .

  1. Think about the health of your children
  2. Wipe the cart down with sanitary wipes
  3. Wash your hands ASAP

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Thursday, December 11, 2008

FDA To Review New Female Condom

Tough situation ahead! There's a new female condom in the pipeline, the FC2, reports this MSNBC article, "New female condom under FDA review - Company didn’t test whether new version prevents pregnancy, STDs." The design is the same as a female condom already on the market. The only difference is what the condom is made of, a new synthetic rubber material called nitrile. The manufacturer says no further studies are needed, and FDA staff are considering whether the company should have conducted specific trials to show how well the FC2 prevents women from contracting diseases or becoming pregnant. Interestingly, the manufacturer's stock price went up today.

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Wednesday, December 10, 2008

FDA Data Guidance - When patients withdraw from clinical trials

How do you handle data when patients withdraw from clinical trials? For a well-written summary, read this post on the FDA Law Blog, "New Guidance Documents Available for When Subjects Withdraw from Clinical Trials." Thanks to Susan Matthees for writing this easily digestible article on the subject that includes links to the two guidance documents.

View more FDA Guidance Documents (free)

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Trackback url for the cited post above:
http://www.typepad.com/t/trackback/2294638/36853634

Tuesday, December 9, 2008

FDA Enforced Laws And Related Statutes


Since this blog covers "GMPs (FDA Good Manufacturing Practices) and other regulations," I guess it's only fair to devote a post to the FDA's "Laws Enforced by the FDA and Related Statutes." They post a pretty exhaustive list of laws and statutes, which they categorize in the following way . . .


Federal Food, Drug, and Cosmetic Act (FD&C Act) United States Code (U.S.C.) Title 21, Chapter 9
Cross-reference of FD&C Act and U.S. Code section numbers
Amendments to the FD&C Act
Other Laws

It should be noted that some of the laws may have been amended since their original date.

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Monday, December 8, 2008

Prescription Project Says DTC Ads Violate FDA Rules

Personally, I dislike direct to consumer (DTC) ads for myriad reasons that I won't go into. I digress. Here's the real news. A consumer watchdog group, The Prescription Project, questioned the legality of several advertisements for medical devices that appear on YouTube, and they want regulators to crack down on the promotions. The Project claims, DTC advertisements for several medical devices on the video Web site YouTube violate federal regulations because they don't include required warnings and disclosures about potential risks. They cite ads for Abbott's Xience V, a drug-coated stent; Medtronic's Prestige Cervical Disc, a spinal implant; Stryker's Cormet hip-resurfacing system; and they want the ads removed from YouTube. The Project's policy director states, "The videos raise serious questions about whether drug and device companies are using the Internet to skirt laws that safeguard consumers." The FDA has roughly six months to respond to the Project's petition.

For a super concise briefing, read this quick read on the Pharma 2.0 blog, "Prescription Project targets medtech ads on YouTube."

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Sunday, December 7, 2008

MedNotes - A New Online Drug List Mgmt Tool - And More! (free)

Check this out! It's a new and interesting twist in the very competitive arena of personal health care records, and drug profile, safety, information, alerts, interactions, and more. The online offerings just keep getting more robust, don't you think?! Drugs.com just unveiled its MedNotes feature, and here's what their press release, "Drugs.com Unveils the Next Generation Medication Safety Tool to Help Consumers Avoid Dangerous Drug Interactions," says about it:

  • Add your medications to instantly assemble relevant medical information in a simple, easy to read personalized format.
  • Gain immediate access to in-depth consumer information, drug comparisons, historical news, FDA alerts, drug interactions, plus food, allergy and medical condition interactions.
  • Choose to be notified when new FDA alerts are issued and when any new drugs become available for any of your existing medical conditions.
  • Create personal, printable health and medication records, including physician and emergency contacts, allergies and existing medical conditions.
  • Use MedNotes to manage medications profiles for yourself and your family.

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Saturday, December 6, 2008

FDA Wants More Asthma Inhalers To Go CFC Free

Current ("old") inhalers use chlorofluorocarbon (CFC) propellants. Because CFCs damage the ozone layer, the FDA will prohibit the sale of CFC inhalers commonly used in the treatment of asthma and other respiratory conditions. This NewsChief article reports that the FDA intends to ban even more CFC-containing inhalers in the future, "Deadlines for other inhalers to go eco-friendly." Here are the highlights that you'll want to know about . . .

  • The most commonly used inhalers (used on a daily basis) go CFC-free by end of 2008
  • Other types of inhalers targeted to go CFC-free after 2008 include: Cromolyn, nedocromil, Combivent, metaproterenol, pirbuterol, flunisolide, triamcinolone, epinephrine.
  • FDA final decisions are pending to give manufacturers enough time to reformulate
Previous Posts:
Switch To New Asthma Inhalers Now - To Get Used To Them

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Friday, December 5, 2008

New Medicare Plan Search Tool - Joppel

Choosing the right plan can be very challenging. Try this newly released tool by Joppel. It's a free tool designed to search Medicare Advantage, Medicare Prescription Drug (Part D) and Medicare Supplement (Medigap) health plans simultaneously from all insurance carriers to match consumers to the plan that fits their coverage needs. It can be so confusing out there, so having access to free tools like this is really wonderful.

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Thursday, December 4, 2008

109 HIV Drugs And Vaccines Under Development

Wow! On the heels of World AIDS day, it's really heartening to see such a robust AIDS/HIV drug and vaccine pipeline. Check out this PhRMA (Pharmaceutical Research and Manufacturers of America) report, "Medicines in Development for HIV/AIDS 2008." Here are some quick hits . . .

  • 29 are vaccines
  • 57 are antivirals
  • they are either in human clinical trials or await approval by the U.S. Food and Drug Administration (FDA)

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Wednesday, December 3, 2008

Nice Review of US FDA Medical Device Regulation

This is an excellent introduction to, and review of the FDA's Medical Device Regulations. This report, "Review of U.S. Medical Device Regulation," published in the Journal of Medical Devices, highlights the differences between regulations guiding medical devices versus pharmaceuticals and underscores the complexity of the approval process and post-market surveillance administered by the Food and Drug Administration (FDA). The report tackles the subject in the following sub-topics . . .

  1. Introduction
  2. Regulatory Definition of Medical Devices
  3. Risk-Based Device Classification
  4. Safety and Effectiveness Requirements
  5. Food and Drug Administration Programs/Regulatory Pathways
  6. Quality Systems Regulation (QSR)
  7. Regulation of Drug-Device Combinations (Combination Products)
  8. Guidance Documents Available to the Device Industry
  9. Conclusions

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Tuesday, December 2, 2008

Think Like An FDA Inspector - Be Prepared


Yep, it's important to follow all the regulations. AND, it helps to understand how the FDA inspector will approach your company during an inspection. On the FDA website, several free documents are published as reference material for investigators and other FDA personnel. The documents don't bind the FDA and don't confer any rights, privileges, benefits or immunities for or on any person(s). Basically, they'll help you prepare and anticipate what to expect from an FDA inspector and inspection team. Just be forewarned, it also means that they don't have to follow the suggestions or recommendations mentioned in the inspection guides. Here's a listing of the major categories of inspection guides that are available . . .

Biotechnology
Biologics
Computer Issues
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Monday, December 1, 2008

FDA Draft Guidance On Proprietary Names


This just released by the FDA, "Draft Guidance for Industry on the Contents of a Complete Submission for the Evaluation of Proprietary Names; Availability." This guidance, "provides recommendations to industry regarding the submission of a complete package that FDA intends to use to assess the safety of proposed proprietary drug and biological product names and other factors that, in association with the name, can contribute to medication errors. In addition, FDA intends to use this information in the assessment of promotional aspects of proposed proprietary names."


Sunday, November 30, 2008

Testing Approved Drugs In The Real World With Real People

In the drug development process, drugs are clinically tested in very select patient populations. This means that once a drug gets approved, the drug is often given to quite a different kind of patient population, and the results of drug treatment could be different. For the big picture, read this compelling Star News Online article, "New Arena for Testing of Drugs: Real World."

I find the story so compelling for the following reasons . . .

  1. Patients, health care professionals, and the pharmaceutical industry bring their own unique health and business issues or needs to the table
  2. It's ultimately about the patient, and there's a need to know whether approved drugs help or harm in the real world

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Saturday, November 29, 2008

Survive - 5 Ways To Get Through The Holidays

Don't miss out on the holiday season. Do your best to celebrate and enjoy it as much as possible. Here are 5 tips from Dr. Jonathan Abramowitz, in his article, "Five tips for surviving the holidays." In a nutshell, the 5 tips (in my own words) are . . .

  1. Recognize your thoughts and emotions, and slow them down
  2. Lower expectations, the holidays don't have to be perfect
  3. Take care of yourself first by modifying and changing how YOU react to people and situations
  4. Place limits on demands and ultimatums by verbally side-stepping them (e.g., replace "should," "must" and "have to" with "I wish," "maybe" and "my preference is ..."
  5. The holiday season is temporary and will be over before you know it

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Friday, November 28, 2008

Pause And Reflect On World AIDS Day (Dec 1)


The fight is far from over. HIV continues to threaten the health of many communities in the United States. CDC data indicate that more than 1.1 million Americans live with HIV, and that an estimated 56,000 new infections occur in the United States every year. Some populations are harder hit than others. For example, it particularly affects gay and bisexual men, and affects African-Americans and Hispanics more than whites. Take a few moments to pause, reflect, and share the following resources widely.

Learn more at the:

CDC HIV/AIDS website - advice, information, fact sheets, brochures, slides, podcasts, reports, resources, and more

AIDS.gov website - Information from the Federal government about HIV/AIDS prevention, testing, treatment, research, and using new media in response to HIV/AIDS - FAQs, podcasts, RSS feeds, blogs, and more

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Thursday, November 27, 2008

Free Calorie Calculator - Find Out How Many You Burn

Whether it's the holiday season or not, find out how many calories you burn, based on your activities, and how strenous they are. "Are you a bionic calorie burner or do you slink along at a slug’s pace? Ever wanted to know how many calories you burn while talking on the phone? Or during sex? Let MSNBC provide that motivational kick you need to get your exercise routine going," says MSNBC in the introduction to its, "Burning off the fat" calorie counter."

I test drove it and was a bit surprised at how few calories I burn. I guess that's because I'm basically a couch potato. Guess I need to watch how many calories I eat.

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Identify Drugs And Pills - Another free identifier resource

Updated October 28, 2018

The MUSC link has broken.

You might also be interested in:



- - -   original post follows below  - - -

Online drug and pill identifiers are like cars. Each one has its own style, and drivers prefer one style over another. Here's another resource, a drug identifier offered by the Medical University of Southern Carolina (MUSC). Enjoy!

Previous Posts:
Drug Identifier - Put one on your PC
Another Free Pill Identifier - for your smart phone or PDA
Identify Those Drugs - Handy Pill Identifier


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Wednesday, November 26, 2008

Carbon Monoxide Poisoning Danger - If it burns, be cautious (video)


They call carbon monoxide the silent killer. That's because fuel burning devices can give off this poisonous gas that you can't see or smell. Learn more about this dangerous gas in this CDC video, "The Quiet Killer."

I'm posting this because we're entering the holiday season. A time when family and friends gather. It's really important to pay attention to the potential causes of carbon monoxide poisoning, and prevent a catastrophe from happening.

Additional Resources:
Protect Your Family and Yourself from Carbon Monoxide Poisoning
Carbon Monoxide Poisoning Prevention Guidelines (available in multiple languages)

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Tuesday, November 25, 2008

Intro To The FDA GMPs - free 3 minute video

This free, short, video clip on YouTube, makes an excellent, "Introduction to Good Manufacturing Practices (GMPs)." This is a nice and easy way to expose new employees to the whole concept of the regulated pharma industry and the FDA regulations. Naturally, this clip is a trailer promotion of a training video sold by the producer. In any event, make use of this very useful, and free video clip.

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Monday, November 24, 2008

6 Free FDA QSR Design Controls Tutorials

Updated 8/10/2016:

You might also be interested in this blog post:
FDA Doubles Down on QbD (BioProcess Blog)

- -  original post follows below  - -

ODDS Company describes itself as an "educational and consulting company that deals with product and process improvements at all levels (from Executive Management to engineering support staff). ODDSCO is particularly useful to medical device manufacturer organizations that always must remain auditably compliant with FDA 21 CFR 820, the Quality System Regulation."

The ODDSCO website offers 6 free tutorials for this reason, "unless basic knowledge of any claimed area of expertise is understood, the value of offered consulting and training services will not be apparent and likelihood of sales is small. But, if the free basic training is perceived as useful and indicative of consultant's knowledge, that likelihood improves. In other words, when equipped with the basic knowledge, a visitor whose organization desires to virtually automate effective QSR Design Controls compliant medical devices development with minimal resources and schedule impact could become a highly qualified customer or client."

The Six (6) Free Tutorials (go to the ODDSCO site for amplified descriptions):
1. Automating FDA QSR Design Controls Compliance
2. Integrated Product/Process Team, Concurrent Engineering, and Systems Engineering
3. The Continuous Improvement Process (CIP) and Total Quality Management (TQM)
4. Knowledge Support Systems (KSS) and Tools
5. An IPPT Supporting Decision Process
6. Project Risk Assessment

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If you are looking for live, onsite, in-person delivered courses or classes, then consider the following popular courses:
Root Cause Analysis & Deviation Investigation Report Writing - cGMP Training
Our most popular course
Qualstar - Pharmaceutical Simulation - Advanced cGMP Training
Put fun back into GMP training!















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Who Offers Live Onsite GMP Training?
SkillsPlus Intl Info Blog

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Sunday, November 23, 2008

Ever Wonder How Bleach Kills Bacteria?

Not my usual kind of post, and for some reason this caught my eye. Perhaps it's because of my microbiology and healthcare training background, and throw in my obsession with cleanliness. I've always just enjoyed and taken for granted, the marvelous cleaning power of bleach. Until now, I've never stopped to consider, "How Bleach Kills Bacteria." This Medical News Today report is fun to read as it . . .

  1. Explains how bleach attacks essential bacterial proteins in a way that's similar to the effect of high temperatures
  2. Discusses hsp33 (heat shock protein) and "molecular chaperones"
  3. Highlights the potential of this finding to give a better understanding of how our bodies might fight off bacterial infections

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Saturday, November 22, 2008

SpermCheck Vasectomy - A Home Test - Medical Device

This recent Journal of Urology abstract, "Clinical and Consumer Trial Performance of a Sensitive Immunodiagnostic Home Test That Qualitatively Detects Low Concentrations of Sperm Following Vasectomy, concludes that SpermCheck Vasectomy, a simple and reliable immunodiagnostic test, can provide evidence of vasectomy success or failure, and offers a useful alternative to improve compliance with post-vasectomy sperm monitoring. It is currently the only FDA-approved test for this purpose.

Monitoring is important because vasectomies are not 100 percent successful, and men who have had them can experience recanalization, or spontaneous healing, leading to restored fertility. Traditionally, after a vasectomy has been performed, the monitoring process involves bringing semen samples to a doctor's office or laboratory at two- and three-month intervals after the procedure. This at-home test is designed to help couples monitor and confirm that post-vasectomy sperm concentrations have reached infertile levels and avoid any surprises. The device is undergoing commercialization through a start-up company.

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Friday, November 21, 2008

Verify Online Pharmacies - Save Money - PharmacyChecker.com

Online pharmacies can offer cost savings, yet they might introduce some risk if you fall prey to unethical pharmacies. Here's a resource that helps navigate through the risk, to that glory land of drug cost savings.

As detailed on their site, "PharmacyChecker.com was founded by a medical doctor in 2003 to help consumers safely save money on medication. It independently checks the credentials of online pharmacies and lets you easily compare drug prices. Its online pharmacy verification program is the largest and most accepted." They offer a report on "Safe Strategies for Drug Savings" that recommends the follow saving strategies . . .

  1. Check brand name prices at Canadian and non-U.S. online pharmacies.
  2. Check brand name prices at U.S. online and wholesale pharmacies.
  3. Check discount generic programs at large retailers and pharmacies.
  4. Check wholesale pharmacy prices on generics.
  5. Check programs based on need or fees.

Previous Posts:
No Prescription Needed - Rogue Pharmacy Sites
8 Tips - Save Money on Prescription Drugs

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Thursday, November 20, 2008

The New iPill - Intelligent pill for drug development

Healthcare IT News reports, "Philips iPill targets treatment for digestive tract diseases" This is a pretty interesting little drug delivery device, fill it up with medication, and it can be programmed to release it as it travels along.

Philips is also known for its FDA-approved "first camera pill" of 2001 used "for diagnostic applications." This new drug delivery device is intelligent pill technology named the 'iPill,' and is designed to aid drug development focusing on new therapies for gastrointestinal (GI) diseases, such as colon cancer. Here are some facts about the iPill . . .

  1. The iPill is swallowed and passes through the GI tract naturally
  2. It can be programmed to release medicine
  3. It measures the local acidity along the GI tract and can report its current location
  4. It also reports local temperatures, and does so wirelessly

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Wednesday, November 19, 2008

Quality by Design (QbD) For Analytical Methods (video)

Updated 8/10/2016:

You might also be interested in this blog post:
FDA Doubles Down on QbD (BioProcess Blog)

- - -
Updated 6/25/2015:

This post didn't age well, the links in the original post are no longer found.

You might also be interested in:   QbD Considerations for Analytical Methods - FDA Perspective

You might also be interested in the following cGMP basics training course:


=========  original post below =========

Maribel Ross, Senior Editor with Pharmaceutical Technology, discusses the FDA's quality by design (QbD) initiative as it applies to analytical methods with one of the top experts in this area, Dr. Moheb Nasr, Director of FDA's Office of New Drug Quality Assessment, in this PharmTech TV video, "Live From 2008 AAPS: Analytical Methods for QbD."

#FDA #GMP #training #cGMP

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If you are looking for live, onsite, in-person delivered courses or classes, then consider the following popular courses:
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Our most popular course
Qualstar - Pharmaceutical Simulation - Advanced cGMP Training
Put fun back into GMP training!














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SkillsPlus Intl Info Blog

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Tuesday, November 18, 2008

FDA Scandal Brewing - Corrupted Scientific Reviews

"Top managers with the U.S. Food and Drug Administration "corrupted and interfered with'' scientific reviews of medical devices, reports this Bloomberg News article, "Democrats Probe 'Corrupted' FDA Reviews of Devices." Wow! What a powderkeg! You have to read this article, because it includes the following words and phrases, yikes!

  1. Corrupted
  2. Interfered with
  3. Reprisals
  4. Threatened
  5. Accept data that isn't scientifically valid
  6. Avoid and evade any accountability
  7. Corruption, illegality, gross mismanagement and retaliation
  8. Felt pressured to alter their work for non-scientific reasons and provide misleading information

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Monday, November 17, 2008

Top 10 Medical Technologies To Watch For In 2009

I love these kind of lists. Trying to peer into the crystal ball is always a most interesting exercise. Here's what the Cleveland Clinic says will shape 2009, as reported in this Chicago Tribune news article, "10 medical technologies to watch in 2009." I give you the list, and you'll want to read the full article to get a better understanding of what this means to our health and our lives. And your top ten are . . .

  1. Circulating Tumor Cell Technology
  2. Warm Organ Perfusion Device
  3. Diaphragm Pacing System
  4. Multi-Spectral Imaging Systems
  5. Percutaneous Mitral Valve Regurgitation Repair
  6. New Strategies for Creating Vaccines for Avian Flu
  7. LESS and NOTES Applications: LESS (laparoendoscopic single-site surgery) takes laparoscopic surgery to a new level by reducing the process to a small cut in the belly button. NOTES (natural orifice transluminal endoscopic surgery) bypasses normal incisions
  8. Integration of Diffusion Tensor Imaging
  9. Doppler-Guided Uterine Artery Occlusion
  10. Private Sector National Health Information Exchange

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Sunday, November 16, 2008

HIV AIDS Bone Marrow Transplant Cure - Skeptical View

Don't get me wrong, I'm excited about this latest case report. However, there are alternate views of what this really means. See what I mean by reading this ABC Health Insider news article, "For AIDS, 'Cure' Is Still a Four-Letter Word." There are a couple of ways to think about this. If bone marrow transplantation really works in the long run, how do we make it widely available and affordable?! If it doesn't work, how long will it take to definitively confirm its ultimate failure?! What's your opinion?

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Saturday, November 15, 2008

Take The Weekend Off - That Means This HIV Med Too?!

Breaking news that taking a certain HIV medication, Atripla (Truvada combined with Sustiva) can be taken just during the weekday, therefore, giving a weekend off. Find out more in the Bloomberg news article, "Gilead AIDS Pill Effective in Study With Weekends Off." This is early research, so it's too early for long-term application. Here's some of the hoped for benefits . . .

  1. This fits into most people's model of a weekday versus weekend life
  2. The reduced schedule could reduce drugs costs by 29%
  3. Viral levels can be kept the same with every day or weekday only regimens

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Friday, November 14, 2008

Web Enabled Drug Bottle Caps - They Remind You

Technology is wonderful. As a pharmacist in this space, I have to say this is exactly what we need. For example, my mother-in-law can't remember when to to take her meds, so this device would really help her. Find out more by reading this Fortune Magazine article, "Vital medicine - Disruptors: Vitality's Web-connected, glowing bottle cap reminds patients to take their pills, potentially saving millions of dollars in healthcare costs." So here's how this new-fangled thing can help . . .

  1. "Vitality" is a wireless gizmo that glows and plays a tune to remind you when it's time to take your medicine.
  2. It keeps track of your doses day by day by counting the times the cap is opened, sending the data to a Vitality-hosted database.

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Thursday, November 13, 2008

Do Not Send Money to FDA Impersonators

It's the latest scam. Someone calls you up, says they're from the FDA (as special agents), and tells you to send money for medications to the Dominican Republic. Don't do it, says this Post Chronicle news article, "FDA Issues Warning About FDA Impersonators." Reportedly, the callers have a Hispanic accent. Once you take the bait, you don't receive any medications, then they threaten to fine you if you don't send a ton of money.

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Gambling With Life - Counterfeit Drugs - Like ED Drugs (Viagra)

As you read this, remember that this is being reported by the BBC. The study mentioned, warns that up to 90% of all medicines sold on the Internet are thought to be fake, reports this BBC News article, "Men warned over counterfeit drugs - Men are being warned they could be "gambling with their lives" if they buy fake medicines online." In a nutshell . . .

  • 1 out of 10 had purchased prescription drugs without a prescription
  • It's thought that up to 90% of all medicines sold via Internet are believed to be fake
  • Men in particular, are not acknowledging the potential risks associated with ingredients contained in counterfeit drugs (e.g., talcum powder, rat poison)

Previous Posts & Other Online Resources:
Caution - Some Dietary Supplements Contain Hidden Drugs
No Prescription Needed - Rogue Pharmacy Sites
FDA: Risks of buying fake erectile dysfunction products on the Internet

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Wednesday, November 12, 2008

Code of Federal Regulations (CFRs) Available Online (free) - Go Green!



This is a wonderful use of our tax dollars. Go green and stop buying hardcopies of the CFRs. On the Goverment Printing Office site, GPO Access, you can slice and dice, search, and browse published CFRs. And if you just can't help yourself, you can always print pertinent text or save portions offered as pdf files. Here's just a sampling of the different ways you can use this site . . .

  1. Listing of all CFR Titles, 1-50 (including annual publications of 21 CFR Food and Drugs since 1996)
  2. 21 CFR Food and Drugs (published April 2008) (including volumes 1-9; chapters I-III; parts 1-1499) falling under the purview of Food and Drug Administration,Department of Health and Human Services ; Drug Enforcement Administration,Department of Justice ; Office of National Drug Control Policy

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Tuesday, November 11, 2008

Caution - Some Dietary Supplements Contain Hidden Drugs

Things aren't always what they seem to be. The same goes for some dietary supplements. An estimated 150 million Americans use dietary supplements, ranging from multivitamins to herbal remedies to specialized mineral blends. So folks need to be careful about what they buy and who they buy it from, reports this Atlanta Journal Constitution article, "Dietary pills laced with drugs - After-market scrutiny: FDA warns about Blue Steel, other supplements that do not have to prove their safety." The government estimates that 30,000 to 40,000 supplement products are being sold by all sorts of companies, some large and reputable, others operating out of a garage or basement. This poses a challenge because regulators are spread too thin, and can only conduct occasional spot checks. Here are some resources that you can reference to try and protect yourself . . .

Dietary pills laced with drugs - After-market scrutiny: FDA warns about Blue Steel, other supplements that do not have to prove their safety (audio)

Resources:
FDA: Recalls & Safety Alerts for dietary supplements and other products
FDA: Risks of buying fake erectile dysfunction products on the Internet

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Monday, November 10, 2008

HIV Treatment Goes Bionic

Bionic man. Bionic woman. Now there's bionic assassins to treat HIV. Researchers have have engineered and tested a killer T-cell receptor that is able to recognize all of the different disguises that HIV is known to have used to evade detection. The researchers attached this receptor to the killer T-cells to create genetically engineered "bionic assassins" able to destroy HIV-infected cells in culture. For the full story, read this EurekAlert, "HIV's disguises no match for 'bionic assassins' - Implications for developing new treatments for AIDS."

Previous Posts:
The Health, Drug, Prescription, and GMP Supersite: HIV Hope and Breakthrough - Abzymes Attack HIV Achilles Heel (video)

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Grand Opening Of Our FDA GMP Online Gift And Award Store!

We're pleased as punch to announce the opening of our online gift store, "The Health, Drug, Prescription, & GMP Online Store." While you're strolling through the aisles, consider picking up something for yourself, your colleagues, or your employees. We imagine you can find items suitable as awards, gifts, reward and recognition, and giveaways in classroom training sessions. Visit the store often, as we intend to expand the inventory over the next couple of weeks. Here's a sampling of the categories you'll find in the store . . .

  1. Bags
  2. Home & Office
  3. Mugs
  4. Cards, Prints, & Calendars

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Sunday, November 9, 2008

Pet Food Sickened People - Did they eat it? . . .

When I saw this headline for the first time, my imagination ran wild and I wondered if people got sick eating the pet food. It turns out it's more about bacterial contamination, as reported by this MSNBC news article, "Pet food sickened at least 79 people, CDC says Kibble tainted with rare salmonella may still be in homes, agency warns." In a nutshell, the contaminated pet food can make people sick if they handle the pet food, especially the very young and very old, and it causes bloody diarrhea. For this reason, the CDC is telling us to be aware that all dry pet food, pet treats, and pet supplements might be contaminated with bacteria like Salmonella, and that precautions should be taken with all brands of dry pet food, treats, and supplements.

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Time To Talk About Turkey Cooking and Food Safety


Thanksgiving is here, and it's time to cook the turkey. Just be sure to follow some basic turkey cooking tips for a delicious turkey without making your family, friends, and guests sick. Here's an excellent tip sheet from the USDA, "Let's Talk Turkey—A Consumer Guide to Safely Roasting a Turkey." A sampling of the tips include, fresh or frozen, stuffing, thawing, microwave, roasting, timetables, and much more . . .

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