FDA - Focus On Opioid Manufacturer REMS FDAAA

Updated September 15, 2016

The original post didn't age well (broken links).

You might also be interested in:
Risk Evaluation and Mitigation Strategy (REMS) for Extended-Release and Long-Acting Opioids (FDA.gov)

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If you're involved in or follow opioid manufacturing, you'll want to follow the FDA's focus on manufacturers of certain opioid drug products. FDA indicates that these drugs will be required to have a Risk Evaluation and Mitigation Strategy (REMS) to ensure that the benefits of the drugs continue to outweigh the risks. The affected opioid drugs include brand name and generic products and are formulated with the active ingredients fentanyl, hydromorphone, methadone, morphine, oxycodone, and oxymorphone. The FDA has authority to require a REMS under the Food and Drug Administration Amendments Act of 2007 (FDAAA) when necessary to ensure that the benefits of a drug outweigh the risks. You can expect to hear more about this over the next several months from the FDA.

More FDA Information About This Topic:
Transcript for FDA's Media Briefing on the Safe Use of Opioids
February 9, 2009 [pdf 52 KF] Audio [5.09 MB MP3]
FDA to Meet with Drug Companies about REMS for Certain Opioid Drugs

Previous Posts:
Opiates Can Kill Kids!

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FDA Advice About Pet Turtles And Salmonella Risk

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Updated December 5, 2021

The original link broke.

You can still read about the same topic here:

Pet Turtles: Cute But Commonly Contaminated with Salmonella - FDA.gov

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Turtles may look like cute pets, but it is estimated that they are responsible for over 70,000 cases of Salmonella infections every year in this country. Some of these infections can be serious or even fatal. In one case, a four week-old infant died of a Salmonella infection that was traced to a pet turtle in the home. In another case, two teenage girls became very ill after they swam in an unchlorinated family pool where pet turtles had been allowed to swim. Read or watch the FDA information about this, FDA report on Potentially Fatal Salmonella Infections from Pet Turtles. Personally, I had trouble viewing the video. But even with that, the text information is still valuable. 

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Primer On Clinical Drug Studies

Updated May 30, 2025

The original link broke.

You might also like this podcast from the FDA on Clinical Trial Basics:

https://www.youtube.com/watch?v=brYANNYW8IY

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Watch this free video and learn about, "Drug Studies: Who, What, When, Where, and Why."

UCTV says, "Almost every American takes a drug every day; many take three or more. This series presented by the UCSF Osher Lifelong Learning Institute explores your medicine, your health and your money. In this episode join John Flaherty, director of medical affairs at Gilead Science, Inc, as he explores the use of drug studies. Series: "UCSF Mini Medical School for the Public" [9/2007] [Health and Medicine] [Show ID: 13072] " 

Related Posts: Global Outsourcing - Clinical Drug Trials - Hot Debate 

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FDA Orange Book Online - Brand New Edition

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

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

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You've been waiting for this. A brand new 29th edition, the 2009 FDA Orange Book Online. The products in this FDA Orange Book have been approved under section 505 of the Federal Food, Drug, and Cosmetic Act. This volume, the 29th edition, is current through December 31, 2008.

According to the FDA, "This publication, Approved Drug Products with Therapeutic Equivalence Evaluations (the List, commonly known as the Orange Book), identifies drug products approved on the basis of safety and effectiveness by the Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act (the Act). Drugs on the market approved only on the basis of safety (covered by the ongoing Drug Efficacy Study Implementation [DESI] review [e.g., Donnatal® Tablets and Librax® Capsules] or pre-1938 drugs [e.g., Phenobarbital Tablets]) are not included in this publication. The main criterion for the inclusion of any product is that the product is the subject of an application with an effective approval that has not been withdrawn for safety or efficacy reasons. Inclusion of products on the List is independent of any current regulatory action through administrative or judicial means against a drug product. In addition, the List contains therapeutic equivalence evaluations for approved multisource prescription drug products. These evaluations have been prepared to serve as public information and advice to state health agencies, prescribers, and pharmacists to promote public education in the area of drug product selection and to foster containment of health care costs. Therapeutic equivalence evaluations in this publication are not official FDA actions affecting the legal status of products under the Act."

Related Posts:
Easy FDA Orange Book Search Widget
About The FDA Orange Book - Slide Deck (free)
FDA Orange Book - Online

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FDA Quality by Design - QbD - Executive Guide (pdf)

According to Cerulean Associates' Why Quality by Design? - An Executive's Guide to the FDA's Quality by Design (pdf), "Quality by Design is one of the most misunderstood and misused tools available to biopharmaceutical and medical device executives." The guide is easily understood and closes by driving to a 7-step QbD start-up plan. According to the guide, "the best way to assess how to implement QbD in your organization without making the same mistakes that other companies have made is to utilize a simple 7 step process."

Here's to hoping you enjoy and find this guide a good read, as I found it.

Related Posts:
Quality by Design (QbD) For Analytical Methods (video)

#FDA #GMP #training #cGMP

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