Tuesday, September 30, 2008

The FDA Drug Approval Process - free video

For those of you wanting something a little more in-depth, here's this free 24 minute video, produced by peRX (prescribing evidence-based therapies), "Why and how are drugs approved?" Here's what the video presents . . .

  1. Overview of drug research and development in the United States, and
  2. The FDA drug approval process

A side note about peRX and this video. The peRX site states, "On May 13, 2004, Warner-Lambert, a division of Pfizer, Inc., entered into an Assurance of Voluntary Compliance/Discontinuance with the Attorneys General of 50 States and the District of Columbia to settle allegations that Warner-Lambert conducted an unlawful marketing campaign for the drug Neurontin® that violated state consumer protection laws. Among other things, the settlement provides for a $21 million Consumer and Prescriber Education grant program." The peRX Project is an educational program funded by the Consumer & Prescriber Education grant program.

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Monday, September 29, 2008

4 Tips To Ensure Your Prescription Safety

It seems as if I'm reading news everyday about some drug safety issue. Here are 4 great tips that you can personally act upon, in order to enhance the safety of prescriptions. For the full details, read this Reader's Digest article, "Prescription Drug Precautions - After a trend in recalled drugs, people are losing faith in the FDA. Find out how to ensure the safety of your prescriptions." In a nutshell, here are the 4 tips at a very high level . . .

  1. Consider enrolling in a clinical trial as a volunteer (a kind of civic duty)
  2. Stick with medications that have been around 4-5 years (the side effects are better known)
  3. Report problems to the FDA
  4. Urge legislators to provide greater funding to the FDA
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Sunday, September 28, 2008

Merck - Pharma Gone Bad

Updated September 27, 2016

The link in the original post finally broke.

You might also be interested in the following in-depth analysis of the same marketing project mentioned below:
When clinical trials are designed by the marketing department

- -  original post follows below  - -

This is all too sad. I suspect this is just the tip of the pharma iceberg. This is a prime example of ethical pharma gone bad. What I find the most fascinating is the internal company struggle between marketing versus bona-fide clinical trial staff. Read the full story in this LA Times news article, "Drug maker Merck's marketing project passed off as research, physicians say."

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Saturday, September 27, 2008

ICYOU - free healthcare 2.0 videos online

This is amazing! There's a whole community here at ICYOU contributing, watching, and commenting on any imaginable health topic. These are free videos. I've embedded the 'What is icyou?' video, so that you can get a better feel for this website.



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Friday, September 26, 2008

The FDA Drug Approval Process


I always have to remind myself what's involved in getting a drug to market. This eSSORTMENT article is short, sweet, and a great overview of the process, "The FDA drug approval process - The FDA has an elaborate clinical process that examines new drugs for distribution to the public with its seal of approval." I've seen it stated in some other places I've read, that it can take about 15 years to 'birth' a new drug.



Thursday, September 25, 2008

The People's Pharmacy Radio Show - Very Popular (Free Podcast)

I'm really glad I found this, and pleased to be able to share this with you. I discovered a large collection of free podcasts on the NPR website. I was particularly interested in the NPR Health and Science podcasts. But, here's what caught my eye. The People's Pharmacy Radio Program Podcast [WUNC] with links and downloads to the latest podcast. Here's the NPR description of the program, "Everything from home remedies to the latest breakthrough drugs are discussed on The People's Pharmacy. Pharmacologist Joe Graedon and medical anthropologist Terry Graedon talk to leading experts to discuss issues relating to drugs, herbs, home remedies, vitamins and related health topics."

I've followed this program for years and have found it incredibly interesting and educational. I hope you will agree.

If you like People's Pharmacy, here are some items you might want:

  1. Best Choices From the People's Pharmacy (book)
  2. La Farmacia Popular: Desde remedios caseros y medicamentos hasta terapias naturales, todas las mejores opciones para vencer 36 males comunes (book)
  3. La Farmacia Popular: Desde remedios caseros y medicamentos hasta terapias naturales, todas las mejores opciones para vencer 36 males comunes (Kindle)
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Wednesday, September 24, 2008

Bisphenol A and the FDA - Is it safe or carcinogenic?!

I don't know what to believe. Here's what I'm reading, US health regulators now seem to think that a chemical, bisphenol A, used to make plastic for baby bottles and food-can liners that has been linked to possible cancer risks is safe at current exposure levels. For a quick easy digestible read, look at this WebMD article, "Bisphenol A Safe, Says FDA." I like the way the subject is presented in the way of 3 'views':

  1. View No.1: No Need to Worry
  2. View No. 2: Cause for Concern
  3. View No. 3: The Precautionary Approach
I think this issue is complex. If you want to see what I mean, just try to read the 105 page draft report just released by the FDA, "Draft assessment of bisphenol A for use in food contact applications."

If plastic baby bottles worry you, then consider buying this book:
Your Baby's First Year (Second Edition)

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Tuesday, September 23, 2008

Deadly Drinking In College - Drinking Games - Alcohol Deaths

It's time to go back to college. There will be drinking. Just don't become a death statistic. This NBC article, "Drinking games prove deadly to college kids," warns that the number of alcohol-poisoning deaths is on rise. The danger is bigger than just having too much alcohol in the body. Just as important is that it impairs judgment and motor skills, and leaves folks prone to assaults. I did a little more research and ran across the following resources, they're quite excellent . . . have a good time, be safe, and don't become a statistic. Be informed.

Additional alcohol resources:

  1. Alcohol and Public Health - a CDC website
  2. College Drinking, Changing The Culture - a website created by the National Institute on Alcohol Abuse and Alcoholism (NIAAA).

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Monday, September 22, 2008

Free WHO Training Guide To GMP Requirements

Updated 9/24/2015:  The original link below is broken. Try this new link:
A WHO guide to good manufacturing practice (GMP) requirements Part 3: Training

=========

This is a wonderful free resource for those involved in or responsible for delivering GMP training or classroom sessions. The World Health Organization (WHO) published this guide, so that it could "help both trainers and supervisors solve some of the problems they face involving training, such as how to make the training interesting to adult learners or how to effectively use a variety of instructional methods."

A WHO Guide To Good Manufacturing Practice (GMP) Requirements, Part 3: Training, is organized by the following major chapters:

  1. Introduction and purpose of this guide
  2. The importance of training
  3. Types of training and content areas
  4. Developing and implementing training
  5. Assessment and evaluation
  6. Administrating a training programme
  7. Questionnaire
You might also be interested in:

Essentials for Pharmaceutical Manufacturers - a training class by SkillsPlus International Inc.
This class teaches employees the essential elements of CGMP for beginning work in the pharmaceutical and biotech industries.
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Sunday, September 21, 2008

Health, Drug, GMP Books On The Kindle Reading Device

This could be the next iPod! I just read about the surge of Kindle (a reading device) sales in this Reuters article, "Citigroup sees better Amazon Kindle sales." Don't have a Kindle yet? Then buy a: Kindle: Amazon's New Wireless Reading Device. If you're not familar with the Kindle, then read this blog post review of the Kindle: All the Best Bits: Kindle Review.

Keeping in the spirit of this blog, here are some Kindle book titles available from Amazon.com:

  1. You: Staying Young: The Owner's Manual for Extending Your Warranty
  2. Smart Medicine: How to Buy the Prescription Drugs You Need at a Price You Can Afford
  3. Handbook of Computer and Computerized System Validation for the Pharmaceutical Industry

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Saturday, September 20, 2008

Free 21 CFR Part 820 QSR Audit Checklist

FDA Guide to Inspections of Quality Systems


Updated 7/23/2013:
Some posts just don't age well (i.e., broken links below). Therefore, you might also be interested in:
FDA- Guide to Inspections of Quality Systems, August 1999

- - -

Don't be caught flat-footed, be ready for the FDA. "Highlight any compliance gaps in your quality management system with a comprehensive FDA GMP Checklist...," says Chris Scholl Consulting Associates. On their site, they offer a free checklist, "21 CFR 820 Audit Checklist." If you don't know where or how to start, they suggest a couple of things to think about, "Are You Ready for the FDA?"

Additional QSR resources:


  1. Compact Regs Parts 820: CFR 21 Part 820 Quality System Regulation (10 Pack)
You might also be interested in:

Surviving an FDA Inspection - a training course by SkillsPlus International Inc.
This class prepares plant personnel to participate in an FDA Inspection.

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SkillsPlus Intl Info Blog

The Exemptee Institute
The Designated Representative Institute

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Friday, September 19, 2008

Free Health Picture Shows - My favorite is Lyme Disease


The folks at MedicineNet.com make this nice collection of educational picture shows (slides with educational text) available for free, MedicineNet.com Picture Shows. Some of the more popular shows include: adult skin problems, bad bugs, ringworm, shingles, and pink eye (conjunctivitis). This is just a sample, there are quite a few more. My favorite is the Lyme Disease picture show.

I find these picture shows very effective because they include high quality photography and short and sweet explanatory text that is concise. Great for self-education about the topics that are available.

Additional reading about Lyme Disease:
Beating Lyme: Understanding and Treating This Complex and Often Misdiagnosed Disease

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Thursday, September 18, 2008

Free GMP Training Tips - Follow adult learning principles

Are you planning an upcoming GMP training session? If you are, every now and then, it's always a good idea to review the principles of adult learning. Then as you're working out the class curriculum and agenda, you can be sure to pay attention to the major adult learning principles and adjust your plan for training. Training grown-ups is challenging. Having an awareness of the challenges is half the battle.

Free resources about adult learning:

  1. Adult Learning Tip 1: Developing a Curriculum
  2. Adult learning Tip 2: Understanding Principles - using training of miners as an example
  3. Adult learning Tip 3: Applying Principles - using training of miners as an example
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Courses, classes, workshops, and seminars - FDA QSR GMP cGMP training


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Wednesday, September 17, 2008

FDA 101: Dietary Supplements - Things you should know


Read this to learn more about dietary supplements. This is another perfect example of how drugs, prescriptions, and dietary supplements intersect the FDA GMPs (good manufacturing practices). According to the FDA, in "FDA 101: Dietary Supplements," ... "The law defines dietary supplements in part as products taken by mouth that contain a "dietary ingredient." Dietary ingredients include vitamins, minerals, amino acids, and herbs or botanicals, as well as other substances that can be used to supplement the diet." You might want to be concerned if you have certain health conditions, because in some instances, if you take these products, you may be putting yourself at risk. The article recommends consulting a health professional if this is your situation. The major topics covered are: talk with a healthcare professional; how are supplements regulated; are supplements safe; be a safe and informed consumer.

The FDA is involved because it stipulates some regulations. For example, "in general, FDA's role with a dietary supplement product begins after the product enters the marketplace. That is usually the agency's first opportunity to take action against a product that presents a significant or unreasonable risk of illness or injury, or that is otherwise adulterated or misbranded."

Additional resources on dietary supplements:
  1. Final Rule Promotes Safe Use of Dietary Supplements - another free consumer-oriented FDA article
  2. The final rule on CGMPs for dietary supplements - available free on the FDA website, these regulations will interest manufacturers
  3. Prescription for Nutritional Healing, 4th Edition (book)
  4. 100 Super Supplements for a Longer Life (Kindle)
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Tuesday, September 16, 2008

Drug and Alcohol Interactions - Have things changed?

How important is the interaction between drugs and alcohol? This US News and World Report article says that alchohol consumption is going down, "Americans Drinking Less Alcohol - Beer consumption is down, while wine consumption is up, study finds." If this is true, you'd think that fewer people would be exposing themselves to drug and alcohol interactions. . . .

Bottomline, "Americans are drinking less alcohol, with middle-aged people consuming about one-third less than 50 years ago, researchers report."

Alcohol can interact with many prescription drugs and cause undesirable adverse effects. It's important to monitor how your medications and alcohol interact.

Additional resources on drug and alcohol interactions:

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Monday, September 15, 2008

Free Pharmaceutical Bioprocessing Glossary

This is a very nice glossary resource from the Cambridge Healthtech Institute (CHI), "Pharmaceutical bioprocessing glossary & taxonomy - Evolving Terminology for Emerging Technologies." This glossary is special because it includes multiple crosslinked hyperlinks. This means that you get both a much richer, and educational experience. This should make a nice addition to your GMP training and classroom efforts. Well-done Healthtech!

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Sunday, September 14, 2008

Structural Aspects of Biomaterials - More than 20 free video lectures

As a taxpaying Californian, this is a pleasant find. In this free video lecture series, Bio Engineering/ME C117: Structural Aspects of Biomaterials, UC Berkeley Professor Lisa Pruitt provides an overview of medical devices, FDA regulatory issues, biocompatibility and sterilization technology. The lectures examine biomechanical properties: isotropy/anisotropy, stiffness, bending stresses, contact stresses, multiaxial loading, plasticity, fatigue, fracture, wear, corrosion, design issues. There are more than 20 lectures in this series . . .

All the available lectures in this series are found via the link above. I've provided the links to the first 2 lectures in the series:

  1. ME C117 Lecture 01: Course Overview
  2. ME C117 Lecture 02: Biocompatibility/FDA Regulatory Agency

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Saturday, September 13, 2008

Free Podcasts - About Herbs and Dietary Supplements

Good stuff! A surprising find. Quite by accident, I found a collection of free podcasts produced by UCSF (University of California, San Francisco), my alma mater. This collection is a series of podcasts from a Candy Tsourounis taught pharmacy school course focused on An Evidence Based Review on Herbs and Dietary Supplements. This is a great example of technology making knowledge sharing so accessible to the general public. Follow the link above, and you'll discover 5 podcasts . . .

  1. The Dietary Supplement Industry - An Overview
  2. Herbs and Supplements in Mental Health
  3. Supplements and the Immune System, Herbal Remedies for Immune Function
  4. Weight Loss Supplements
  5. Glucosamines, Omega 3 Fatty Acids

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Friday, September 12, 2008

Cool FDA Drug Information Widgets - Free!

I have to admit that I love a good toy. But this is even better. These free drug information widgets from the FDA can be found here, "Add FDA Drug Information Links to Your Web Site." These widgets make it possible for you to insert links to FDA content into your own Web pages. FDA widgets contain links to FDA Web pages and resources on common topics. ...











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Thursday, September 11, 2008

Drug Identifier - Put one on your PC

Put this on your PC. It's software that can help you identify prescription drugs lying around, whatever the reason, your pills, a friend's, maybe your children's medication . . .

  1. 2008 Drug Identifier: Published by Facts & Comparisons (Drug Identifier (CD-ROM))
  2. Drug Identifier 2009 (Drug Identifier (CD-ROM))

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Wednesday, September 10, 2008

Free GMP Glossary

Post Updated 5/6/2012:
The link in the original post, and 1st revision, no longer exist.  I offer you this alternative link instead:
The GMP Experts of Maas and Peither have published an Online GMP Glossary free of charge.

I'm continually amazed at all the fabulous free GMP resources that can be found on the web. Take a look at this GMP Glossary made available by the Maas & Peither GMP Publishing Team. This team's description, "Definitions of GMP terms derived from EU, FDA and ICH guidelines are the base of your GMP communication and documentation."

They're right. Not only can your communication and documentation be made more precise, you can use this glossary for your GMP training efforts and classroom training.

Previous posts on FDA GMP training:

  1. The Health, Drug, Prescription, and GMP Supersite: 4 Free Articles on GMP Training
  2. The Health, Drug, Prescription, and GMP Supersite: Free GMP Training Tip - Your Homework Is To Sleep Before Class
  3. The Health, Drug, Prescription, and GMP Supersite: 2 Free GMP Training Tips - Make It Fun!
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Tuesday, September 9, 2008

20 Money Saving Tips on Prescription Drugs

I ran across an eSearch article about saving money on drugs. The article references a book just about cost-saving methods, "How to Save on Prescription Drugs: 20 Cost-saving Methods." You can never get enough of these kind of tips. In a nutshell, here are the broad strokes to cut down on costs . . .

  1. Eliminate non-essential prescriptions (e.g., ones that no longer work)
  2. Think outside the prescription bottle (e.g., make lifestyle changes)
  3. Steer clear of overpriced redundant drugs (e.g., take generic drugs)
  4. Play it smart (e.g., comparison shop)

Additional resources about saving money on prescription drugs:
  1. How to Save on Prescription Drugs: 20 Cost-saving Methods
  2. The Health, Drug, Prescription, and GMP Supersite: 8 Tips - Save Money on Prescription Drugs

    More Popular and Top-Ranked Online Health Resources

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    Monday, September 8, 2008

    Health Dangers In Flood Waters - Health Tips

    With all the hurricanes and inclement weather around us, we've got some flooding going on. If you find yourself in flood waters, here are some very important health tips to follow, and health issues to consider . . .

    1. Flood waters can contain fecal material from overflowing sewage systems as well as other contaminants from a variety of sources.
    2. There is a risk of disease from eating or drinking anything contaminated by flood water.
    3. If you have open cuts or sores that will be exposed to flood water, keep them as clean as possible by washing well with soap to control infection. If a wound develops redness, swelling or drainage, promptly seek medical attention.
    4. Fish or seafood caught from these waters should be thoroughly cooked prior to eating. After handling fish and seafood, be sure to thoroughly wash your hands with soap and clean water.

    Source: Public Reminded To Use Caution In Flood Waters

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    Sunday, September 7, 2008

    Do You Know About Telepharmacies?

    This is a new one for me. I live in a big city so I've never really thought about this. But for many who live in isolated rural areas, you'll want to read this Houston Chronicle news article, "Telepharmacies change the way rural America gets meds." Here are the key points that I get out of this article . . .

    1. Telepharmacies are real drug stores staffed mostly by registered pharmacy technicians or registered nurses
    2. They're in North Dakota, and a handful of other states
    3. The workflow can go something like this, "The pharmacy technicians use remote cameras to show pharmacists [at another location] the original signed prescription, computer-generated label, stock bottle where the pills are stored and the bottle the patient will take home. Once the prescription is approved, patients have a mandatory private consultation with pharmacists through real-time video and audio."

    In a nutshell, getting medications by mail is no longer the only option in some places; telepharmacies can make it possible for patients to interact with real people in a real drug store setting, even though a pharmacist isn't on-site.

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    Web Health Tools - Free

    Use these cool tools to take care of your health. I just love the web! There are these free health tools and resources all over the place. Here's just a sample . . .

    1. AARP Symptom Checker - just enter your symptoms to find out the possible causes
    2. Kaiser Permanente Drugs and Natural Medicines - giant databases of information
    3. AARP Illustrated Health Encyclopedia
    4. AHA body mass index (BMI) calculator - a measure of body fat based on height and weight
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    Saturday, September 6, 2008

    5 or More Drinks - Increases STD risk

    No surprise. If you drink heavily, your judgement drops, and you're at greater risk of picking up a sexually transmitted disease (STD), reports this LA Times news article, "Binge drinking is fun -- until the gonorrhea diagnosis." Here are the highlights of this article . . .

    1. Drinking five or more alcoholic beverages at one time appears to be connected to risky sexual behaviors and higher rates of STDs
    2. As far as the actual sex, women are more likely to contract some diseases, such as HIV, through repeated condomless intercourse than are men

    Additional information on this topic:

    1. Women who binge drink at greater risk of unsafe sex and sexually transmitted disease (news release)
    2. CDC - Quick Stats - Binge Drinking

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    This Blog Has Gone Mobile - The Health, Drug, Prescription, and GMP Supersite

    Our posts are now available for mobile viewing too! So here's what will happen.

    We'll maintain our original Blogger blog, here at: http://drughealth.blogspot.com/
    I'll continue to post new content here.

    Mobile phone readers can view our posts via this url: http://drughealth.mofuse.mobi/
    Here's what happens. When I post to Blogger, an RSS feed gets sent to our mobile blog site hosted on MoFuse. You'll just be viewing our mobile optimized content with the help of the fine folks at MoFuse. What's cool is from our original Blogger site (look at the 'sidebar'), you can send yourself the mobile blog link to your phone. We also supply you with a link to the mobile site too.

    Happy reading!

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    Friday, September 5, 2008

    Big Medical Bills - experts say almost all are wrong (video)

    If you find yourself on the wrong end of a huge, massive medical bill, then you need to checkout this CBS News video, "Truth About Hospital Bills." There's also an accompanying article you can read. Here's what I find so interesting from it . . .

    1. Millions of "balance bills" sent to patients these days are either illegal - or they are highly inflated.
    2. Two billing investigators cited in the video say that overbilling is now the norm.
    3. Be sure to get an itemized bill, scrutinize and question every single charge, and dispute overcharges with the hospital.
    4. You might want to consider getting help by hiring a billing advocate.
    5. Consider complaining to the Attorney General
    For additional free resources on medical-bill fraud, or on "balance billing:"
    Resources: Health Care Billing Fraud - Think You're A Victim Of Healthcare Billing Fraud? Check Out These Resources (CBS News)

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    Thursday, September 4, 2008

    FDA Orange Book - Online


    FDA Orange Book - Online


    Updated Aug 18, 2016:
    FDA's redesigned Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (webpage)

    - -  original post follows below  - -

    In case you didn't know, the FDA's Orange Book is now available online. The folks at Foley & Lardner LLP state, "The FDA's Approved Drug Products List with Therapeutic Equivalence Evaluations, commonly referred to as the Orange Book, was introduced in 1979, and since its introduction has unquestionably been the authoritative reference source for drug products approved by FDA under the Federal Food, Drug & Cosmetic Act. No longer a printed book, but a database available on FDA's website, the Orange Book lists all products that have been approved by FDA for safety and effectiveness, and explains the therapeutic equivalence code for multi-source products." The FDA website makes the following Orange Book resources available to you . . .
    1. Orange Book Query - The Electronic Orange Book Query enables searching of the approved drug list by active ingredient, proprietary name, applicant holder or applicant number.
    2. Orange Book Annual Edition (28th Edition) - The publication identifies drug products approved on the basis of safety and effectiveness.
    3. Orange Book Current Cumulative Supplement - The monthly Cumulative Supplement publication provides information on newly approved drugs, changes and revisions to current data including therapeutic equivalence evaluations, and updated patent and exclusivity data.
    4. Orange Book - Information and Data Files - Text files for importing into databases.
    5. Orange Book Monthly Additions and Deletions - Changes to the annual edition are listed separately by month.
    6. Frequently Asked Orange Book Questions
    7. Frequently Asked Patent and Exclusivity Questions
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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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    Wednesday, September 3, 2008

    Medical Devices Containing Antimicrobial Agents - FDA Guidance Pending

    Updated January 16, 2017

    The link in the original post is no longer valid.

    You might be interested in the guidance document:
    Draft Guidance for Industry and FDA Staff - Premarket Notification [510(k)] Submissions for Medical Devices that Include Antimicrobial Agents

    - -  original post follows below  - -

    Here's a late-breaking scoop from FDA Legislative Watch, "FDA Finalizing Guidance For Devices Containing Antimicrobial Agents." Reportedly, revisions to a draft guidance on 510(k) submissions for devices or combination products that incorporate antimicrobial agents are awaiting final sign-off at the FDA. Apparently, one of the biggest issues for debate is whether a device is substantially equivalent to a marketed product with the same design, or whether it is a modification. Bottomline, modified devices require much more data.

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    Our most popular course
    Qualstar - Pharmaceutical Simulation - Advanced cGMP Training
    Put fun back into GMP training!














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    TrackBack URL for the article cited above:
    http://www.typepad.com/t/trackback/1100022/33049446

    Your Medical Record Can Save Your Life!

    Bottomline, doctors pay attention to what's in your medical record. This ABC News article is enlightening, "Healthy Dose: How Medical Records Can Save Your Life - Taking Charge of Your Medical Records Helps Safeguard Your Health." Here are some tips mentioned in the article that can safeguard your health . . .

    1. Collect your test results and specialist's consultation reports
    2. Locate as many existing records as possible and fill in the gaps on your own
    3. Craft ongoing logs, journals and information sheets that contain life-saving facts that only you can provide
    4. Create an emergency health information card to carry with you at all times
    5. Take an active stance in working with your health-care team in preventing and managing health problems

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    Tuesday, September 2, 2008

    New FDA Guidance - cGMP Practice for Phase 1 Investigational Drugs


    There was lots of coverage on this recently released FDA guidance, "Guidance for Industry - CGMP for Phase 1 Investigational Drugs. " (PDF) I'm posting the link to this guidance so that it can be easily found and downloaded. Here's what the introduction in the guidance says . . .
    • This guidance is intended to assist in applying current good manufacturing practice (CGMP) required under section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) in the manufacture of most investigational new drugs (IND) used in phase 1 clinical trials.2 These drugs, which include biological drugs, are exempt from complying with 21 CFR part 211 under 21 CFR 210.2(c) (referred to as phase 1 investigational drugs).

    • Because a phase 1 clinical trial initially introduces an investigational new drug into human subjects, appropriate CGMP help ensure subject safety. This guidance applies, as part of CGMP, quality control (QC) principles to the manufacture of phase 1 investigational drugs (i.e., interpreting and implementing CGMP consistent with good scientific methodology), which foster CGMP activities that are more appropriate for phase 1 clinical trials, improve the quality of phase 1 investigational drugs, and facilitate the initiation of investigational clinical trials in humans while continuing to protect trial subjects.

    • This guidance replaces the guidance issued in 1991 titled Preparation of Investigational New Drug Products (Human and Animal) (referred to as the 1991 guidance) (Ref. 1) for the manufacture of phase 1 investigational drugs described in this guidance (see section III). However, the 1991 guidance still applies to the manufacture of investigational new products (human and animal) used in phase 2 and phase 3 clinical trials.

    • The guidance finalizes the draft guidance entitled "INDs—Approaches to Complying with CGMP During Phase 1" dated January 2006; and is being issued concurrently with a final rule that specifies that 21 CFR part 211 no longer applies for most investigational products (see section III), including certain exploratory products (Ref. 2) that are manufactured for use in phase 1 clinical trials. The agency recommends using the approaches outlined in this guidance for complying with § 501(a)(2)(B) of the FD&C Act.

    • FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.

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    Monday, September 1, 2008

    Shocking - Health Care Costs (multimedia)

    Uggggh! Take a gander at these visuals about health care costs. Nothing pretty going on here. The statistics are presented by MSNBC, "Health Care & Costs, By The Numbers." Here's what they show . . .

    1. Texas has the highest percentage of uninsured (24.5%)
    2. Over 33% of the U.S. poor, and nearly 30% of the 'near poor' lack health coverage
    3. In the last decade, more people delay or don't pursue medical treatment due to the lack of coverage, and rising cost of medical coverage
    4. In 2004, the U.S. spent $6,102 per person on health care
    5. 46.2% of those filing for bankruptcy in 2001 cited medical causes

    It seems to me that our health care system is broken, and we need to find a way to reform the healthcare system.

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