Monday, February 6, 2012

It's Here! 2012 FDA Orange Book!

It finally arrived!

The FDA Orange Book for 2012 (32nd Edition)  has just been posted. It's current through Dec 31, 2011.

It's also posted in this location:
FDA - Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations: Publications

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Thursday, February 2, 2012

FDA and industry reach agreement in principle on medical device user fees

The agreement in principle is the result of over a year of negotiations between the FDA and industry. It strikes a careful balance between what industry agreed to pay and what the FDA can accomplish with the amount of funding proposed. It would result in greater accountability, predictability, and transparency through such improvements as a more structured pre-submission process and earlier interactions between FDA and applicants. With the additional funding, the FDA would be able to hire over 200 full-time equivalent workers by the end of the five-year program. The FDA and industry expect that the agreement in principle would result in a reduction in average total review times.


Press Announcements - FDA and industry reach agreement in principle on medical device user fees:
"FDA and industry reach agreement in principle on medical device user fees

The FDA and representatives from the medical device industry have reached an agreement in principle on proposed recommendations for the third reauthorization of a medical device user fee program.

The recommendations would authorize the FDA to collect $595 million in user fees over five years, plus adjustments for inflation. Details of the agreement, such as the fee structure, are expected to be finalized soon.

Under a user fee program, industry agrees to pay fees to help fund a portion of the FDA’s device review activities while the FDA agrees to overall performance goals such as reviewing a certain percentage of applications within a particular time frame."
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Tuesday, January 31, 2012

Counterfeit Medicine - On the FDA Website

Counterfeit drugs
Image via Wikipedia
The FDA has a nice constellation of items and articles related to counterfeit medicine.

Counterfeit Medicine - US FDA Website:
"Counterfeit Medicine - Counterfeit medicine is fake medicine. It may be contaminated or contain the wrong or no active ingredient. They could have the right active ingredient but at the wrong dose. Counterfeit drugs are illegal and may be harmful to your health. 
FDA takes all reports of suspect counterfeits seriously and, in order to combat counterfeit medicines, is working with other agencies and the private sector to help protect the nation's drug supply from the threat of counterfeits."
'via Blog this'

Free information and resources about counterfeit medicine:
US FDA Website - Counterfeit Medicine

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Monday, January 30, 2012

FDA Supplement Guidance Not Strict Enough, MD Says

This is pretty controversial stuff, as the dietary supplement industry largely opposes the draft regulation

Medical News: FDA Supplement Guidance Not Strict Enough, MD Says - in Public Health and Policy, FDA General from MedPage Today:

"An FDA proposal to require dietary supplement manufacturers to submit data proving their product is safe doesn't go far enough, according to a physician writing in the New England Journal of Medicine.  
More than 100 million Americans spend more than $28 billion on vitamins, minerals, herbal ingredients, amino acids and other natural products in the form of dietary supplements each year, "assuming they are both safe and effective," wrote Pieter A. Cohen, MD, of Harvard Medical School and the Cambridge Health Alliance. 
But they have no assurance that the products are safe because FDA regulation of supplements is too weak, Cohen wrote in a Perspective piece."
'via Blog this'

Read more about this:
FDA Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues

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Wednesday, January 25, 2012

FDA issues first social media rules for drug companies

amednews: FDA issues first social media rules for drug companies : Jan. 25, 2012 ... American Medical News:

"The Food and Drug Administration is giving pharmaceutical companies some rules for how they interact with consumers on social media. But the companies say they need a lot more clarification from the FDA before they're comfortable getting back online again. 
The draft guidance encourages all responses to unsolicited requests for information, which could include requests from physicians for information on off-label uses for certain drugs, to be made in a nonpublic format."
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Read this draft guidance:
FDA - Guidance for Industry - Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices (PDF)

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Sunday, January 22, 2012

Pot-based Prescription Drug Looks For FDA OK

This caught my eye. I had no idea there were products in the pipeline.

Pot-based Prescription Drug Looks For FDA OK | Fox News:
"A quarter-century after the U.S. Food and Drug Administration approved the first prescription drugs based on the main psychoactive ingredient in marijuana, additional medicines derived from or inspired by the cannabis plant itself could soon be making their way to pharmacy shelves, according to drug companies, small biotech firms and university scientists.

A British company, GW Pharma, is in advanced clinical trials for the world's first pharmaceutical developed from raw marijuana instead of synthetic equivalents — a mouth spray it hopes to market in the U.S. as a treatment for cancer pain. And it hopes to see FDA approval by the end of 2013.

Sativex contains marijuana's two best known components — delta 9-THC and cannabidiol — and already has been approved in Canada, New Zealand and eight European countries for a different usage, relieving muscle spasms associated with multiple sclerosis."
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Friday, January 20, 2012

Fact: 80 percent of U.S. pharmaceuticals made with overseas ingredients, nearly half produced in foreign facilities never inspected by FDA

Fact: 80 percent of U.S. pharmaceuticals made with overseas ingredients, nearly half produced in foreign facilities never inspected by FDA:

"Issued by the US Government Accountability Office, the new report says up to 40 percent of all pharmaceuticals sold in the US are actually manufactured overseas in countries like India and China. A whopping 80 percent of all ingredients used to manufacture drugs, including those manufactured in the US, reportedly come from overseas as well. And the FDA has inspected a mere 11 percent of all foreign drug manufacturing facilities, as opposed to the 40 percent it has inspected domestically."
'via Blog this'

Drug lobby wants clearer FDA rules for diet pills

Drug lobby wants clearer FDA rules for diet pills | Reuters:

"Over the past year, the FDA has drawn fire from some manufacturers for being too cautious in reviewing medical products, hindering U.S. innovation.

They point to obesity drugs, where Arena Pharmaceuticals, Orexigen Therapeutics and Vivus have hit roadblocks in gaining approval for their diet pills because of potential safety concerns."
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Thursday, January 19, 2012

FDA to weigh safety of tobacco lozenges, strips

I have mixed feelings. I know that I strongly dislike being around cigarette smoke. And I also understand the dangers and potential poisoning risks that these products pose.

FDA to weigh safety of tobacco lozenges, strips - USATODAY.com:
"Dissolvables" are flavored mints, strips and sticks of smokeless tobacco. These products are not stop-smoking aids. Instead, they are designed to allow people to satisfy their cravings for nicotine in places where smoking is banned."
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US counterfeit drug seizures up 200 per cent in 2011

SecuringPharma - US counterfeit drug seizures up 200 per cent in 2011:

"China remained the primary source of counterfeit goods across all categories, representing 62 per cent of all seizures by value, with the value of pharmaceutical seizures from China increasing by more than $4.3m and the value of perfume seizures up $7m on the prior year.

Meanwhile, India and Pakistan both featured in the top 10 source countries in 2011, mainly due to seizures of counterfeit pharmaceuticals. Pharmaceutical seizures accounted for 86 per cent of the value of seizures from India and 85 per cent from Pakistan, said the CBP.

The top 10 source countries - in descending order - were: China; Hong Kong; India; Pakistan; Taiwan; Switzerland; Malaysia; South Korea; UK; and Mexico."
'via Blog this

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America Is Drunk

America Is Drunk | Fox News:

"According to the Centers for Disease Control, we’re becoming a nation of drunks. Booze hounds on benders.

New data reveals that one in every six Americans downs eight mixed drinks within a few hours, four times a month. Twenty-eight percent of young people between the ages of 18 and 24 binge-drink five times a month, putting away seven drinks in one sitting. And 13 percent of those between the ages of 45 and 65 binge drink five times a month, too."
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Wednesday, January 18, 2012

FDA Inspection Preparation

Don't get surprised!  Prepare yourself well in advance of an FDA inspection.

But if you should find yourself on the brink of one in a week or so, here's something helpful:
Rapid Deployment Tips to Prepare for an Inspection Quickly by John Avellanet (PDF)

If you're not so much in a rush, then invest some time in getting prepared.

You might be interested in:
Surviving an FDA Inspection - a live onsite training class

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Tuesday, January 17, 2012

FDA Says Drug Shortages Raise Risk of Cancer Counterfeits

The FDA published this notice. Looks like drug shortages are opening doors for bad actors to take advantage of the situation.

FDA Notifies Health Care Providers about the Risks of Purchasing Unapproved Injectable Cancer Medications from Unlicensed Sources
Current shortages of injectable cancer medications may present an opportunity for unscrupulous individuals to introduce non-FDA approved products into the drug supply, which could result in serious harm to patients. Health care providers are reminded to obtain and use only FDA-approved injectable cancer medications purchased directly from the manufacturer or from wholesale distributors licensed in the United States (U.S.).
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Monday, January 16, 2012

College-age adults average 9 alcoholic beverages when they binge drink

Alcoholic beverages
Image via Wikipedia
This was somewhat thought-provoking. . .  if you go to a dinner party and have 4-5 or more glasses of wine over at least that number of hours, does that also qualify as binge drinking?  hmmm

College-age adults average 9 alcoholic beverages when they binge drink, CDC report says - The Washington Post:
"College-age drinkers average nine drinks when they get drunk, government health officials said Tuesday. That surprising statistic is part of a new report highlighting the dangers of binge drinking, which usually means four to five drinks at a time. Overall, about 1 in 6 U.S. adults surveyed said they had binged on alcohol at least once in the previous month, though it was more than 1 in 4 for those ages 18 to 34."
'via Blog this'

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Even More Resources, Books, & Things (many from Amazon.com)

FDA, GMPs, QSR, GCP, GLP, GXP:
21 CFR Parts 210 and 211: Drug Industry GMP's     Compact Regs Parts 807, 812, and 814: CFR 21 Parts 807, 812, and 814 Medical Device Approval (10 Pack)     The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices     Compact Regs Part 11: CFR 21 Part 11 Electronic Records; Electronic Signatures (10 Pack)     How to Fail an Fda Quality Audit: A Look at Some of the Causes of Failure to Comply With Fda Quality Regulations     Pharmaceutical Master Validation Plan: The Ultimate Guide to FDA, GMP, and GLP Compliance     How to Develop and Manage Qualification Protocols for FDA Compliance         Agent GXP FDA Part 11 Guidebook: The FDA Regulations on Part 11, Electronic Records and Electronic Signatures, For Pharmaceutical, Medical Device, Food, ... Trials and GCP (Good Clinical Practices)     Development of Fda-Regulated Medical Products: Prescription Drugs, Biologics, and Medical Devices     FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics     Design and Analysis of Clinical Trials: Concepts and Methodologies (Wiley Series in Probability and Statistics)     Clinical Studies Management: A Practical Guide to Success     Analytical Chemistry in a GMP Environment: A Practical Guide     Process Validation in Manufacturing of Biopharmaceuticals: Guidelines, Current Practices, and Industrial Case Studies (Biotechnology and Bioprocessing Series)     Pharmaceutical Equipment Validation: The Ultimate Qualification Guidebook     Preclinical Drug Development (Drugs and the Pharmaceutical Sciences)     Group Sequential Methods: Applications to Clinical Trials (Chapman & Hall/Crc Interdisciplinary Statistics Series)     Validation Standard Operating Procedures: A Step by Step Guide for Achieving Compliance in the Pharmaceutical, Medical Device, and Biotech Industries, Second Edition     Pharmaceutical Stress Testing: Predicting Drug Degradation (Drugs and the Pharmaceutical Sciences)     Cleaning Validation: A Practical Approach     Validated Cleaning Technologies for Pharmaceutical Manufacturing     Risk-Based Compliance Handbook     Microbiology in Pharmaceutical Manufacturing, Second Edition, Revised and Expanded, Volume I (1)     Microbiology in Pharmaceutical Manufacturing, Second Edition, Revised and Expanded (Volume 2)     Bioprocess Validation: The Present and Future     Laboratory Validation: A Practitioner's Guide     Quality Assurance Workbook for Pharmaceutical Manufacturers     Risk-based Software Validation: Ten Easy Steps     ISO 13485 and FDA QSR Internal Audit Checklist     ISO 13485:2003 & FDA QSR (21 CFR 820) Quality Manual, 34 Procedures and Forms
Training Resources:
1001 Ways to Reward Employees     Planning Programs for Adult Learners: A Practical Guide for Educators, Trainers, and Staff Developers, 2nd Edition     50 Creative Training Openers and Energizers     Personalized M&M Candies     Oriental Trading Co - Training toys and supplies     GMP Training Gifts & Giveaways     GMP Training & Quality Posters