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.

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- - 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, "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:
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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 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.

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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 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

Updated April 17, 2019

The links in the original post broke.

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Human Factors and Medical Devices on

---  original post follows below  ---

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
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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 . . .

Scope and Authority
Organization and Personnel
Facility Operation
Protocol and Conduct
Records and Reports

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 . . .

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 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?

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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.

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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:
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Medical Devices Containing Antimicrobial Agents - FDA Guidance Pending
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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?

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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?

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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:

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)

Updated April 16, 2019

Some of the links broke in the original post below.

The MedNotes (aka My Med List) feature link still works.

You might also be interested in the smartphone app that includes the My Med List functionality: Medication Guide

 - - -  Original Post Follows Below  - - -

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?! just unveiled its MedNotes feature, and here's what their press release, " 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
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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 . . .

Computer Issues
Foods Cosmetics

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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."

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