The Generic Drugs You're Taking May Not Be As Safe Or Effective As You Think - NPR.org

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Read the full article:  The Generic Drugs You're Taking May Not Be As Safe Or Effective As You Think - NPR.org

"Eban has covered the pharmaceutical industry for more than 10 years. She notes that most of the generic medicines being sold in the U.S. are manufactured overseas, mostly in India and China. The U.S. Food and Drug Administration states that it holds foreign plants to the same standards as U.S. drugmakers, but Eban's new book, Bottle of Lies, challenges that notion. She writes that the FDA often announces its overseas inspections weeks in advance, which allows plants where generic drugs are made the chance to fabricate data and results."

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Dirty Medicine - A Fortune Feature - A Must Read!

This is a must-read . . .

Dirty medicine - Fortune Features:

"On May 13, Ranbaxy pleaded guilty to seven federal criminal counts of selling adulterated drugs with intent to defraud, failing to report that its drugs didn't meet specifications, and making intentionally false statements to the government. Ranbaxy agreed to pay $500 million in fines, forfeitures, and penalties -- the most ever levied against a generic-drug company."


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Too Little Reward For Quality - Drives Generic Injectable Shortages

Clinical Pharmacology & Therapeutics - Economic and Technological Drivers of Generic Sterile Injectable Drug Shortages:

"Over the past few years, an increasing number of critically needed medicines have been in short supply. Using economic theory to frame the drug-shortage problem, this paper explores why and how manufacturing-quality problems could combine with other economic and technological factors to result in shortages of generic sterile injectable drugs. The fundamental problem we identify is the inability of the market to observe and reward quality. This lack of reward for quality can reinforce price competition and encourage manufacturers to keep costs down by minimizing quality investments."

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FDA on the Ranbaxy Atorvastatin Recall

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The FDA is providing additional related information. Just follow the link below.

Drug Safety and Availability > FDA Statement on the Ranbaxy Atorvastatin Recall:

"FDA Statement on the Ranbaxy Atorvastatin Recall

Update: 11/30/2012
FDA is notifying the public that after reviewing additional information related to the Ranbaxy atorvastatin recall, FDA has determined that the possibility of adverse health problems related to the recalled atorvastatin is extremely low.

What patients should know . . . "

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Ranbaxy Generic Lipitor Recalled

Generic Lipitor Recalled - Another Sign The FDA Needs Help? - Forbes:

The Ranbaxy recall comes after a host of problems with Ranbaxy in recent years – including recalls, admissions of false testing data presented to the FDA, and other manufacturing problems. The troubles at Ranbaxy also point to the challenge a foreign drug company has when buying another drug company. Almost immediately after Daiichi Sankyo acquired a majority stake in Ranbaxy, problems sprang up.  With no expertise running an Indian generics drug company, let alone one that had been family controlled up to that point, DaiichiSankyo was blindsided by the troubles."

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Google Medication Search

Updated November 30, 2020

The original post is now out of date.

You might also like:

Drug Information Portal - NIH

- - -  original post follows below  - - -

This should interest those of you looking up drug information on the web.

Google's new medications search feature displays ASHP's (The American Society of Health-System Pharmacists) consumer medication information, which is licensed by the National Library of Medicine.

Just Google a drug name and there it is!

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About The FDA Orange Book - Slide Deck (free)

Updated Feb 3, 2016:
It's here! The latest Orange Book Annual Edition

You might also be interested in this webpage:
FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

- - - original post below - - -

If you use the FDA's Orange Book, or have an interest in generic drugs, exclusivity, and patents, then take a gander at this slide deck from an FDA CDER staff member, "The Orange Book (slide deck; free)." The slide deck covers . . .

• What is the Orange Book?
• What is exclusivity and how does it work?
• How is the Food and Drug Administration (FDA) involved with patent protection?

Related Posts:
FDA Orange Book - Online

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Residual Solvent Coalition Formed - Gets FDA Attention On USP Chapter 467

Updated May 31, 2021

The original link broke.

You can read more about this topic here:

FDA Answers Key Residual-Solvent Testing Questions - PharmTech.com

---  the original post follows below  ---

When the FDA published its recent guidance document on residual solvents in drug products, it resulted in confusion and generated many questions. This recent PharmTech Talk post does an excellent job of framing the difficult situation, "Residual Solvent Concerns Lead to Coalition." In a nutshell, here are some of the important points PharmTech Talk makes . . .

1. Industry has experienced a number of problems and confusion regarding the draft guidance and communications received from FDA’s Office of Generic Drugs, that seem to conflict with Chapter 467
2. There have been so many problems that some core industry groups formed the Coalition for Rational Implementation of USP General Chapter <467>
3. The coalition had four key areas of concern: 1) testing versus control, 2) identification of Class 3 solvents, 3) use of Class 1 solvents, and 4) need for immediate relief while awaiting revised guidance.

Stay tuned, as there's hope the FDA will respond within the next couple of weeks. 

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Hi-Tech Pharmaceuticals - Purported assassination, blackmail plots

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This reads like a TV show. Sadly, it's all too real. You'll want to share this story during your GMP training and classroom teaching. The courtroom charges were conspiring to import and distribute adulterated, mislabeled and unapproved new drugs and to commit mail and wire fraud. Even more outrageous is a mention that the defendants allegedly conspired to murder a U.S. Food and Drug Administration agent and blackmail a former assistant U.S. attorney general.

For the full story, read this MSNBC article, "From diet supplements to illegal Net pharmacy - Ga. firm, 3 execs plead guilty to selling generic prescription drugs online."

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