New EU GDP Guidelines Published

Quality and integrity of medicinal products are key factors that must be maintained during the entire supply chain from the manufacturer to the patient. The European Commission revised the guidelines that lay down appropriate tools to assist wholesale distributors in conducting their activities and to prevent falsified medicines from entering the legal supply chain.

Wholesale distribution of medicinal products is defined as "all activities consisting of procuring, holding, supplying or exporting medicinal products, apart from supplying medicinal products to the public. Such activities are carried out with manufacturers or their depositories, importers, other wholesale distributors or with pharmacists and persons authorized or entitled to supply medicinal products to the public in the Member State concerned."

The revised EU GDPs, Good Distribution Practices, become effective September 8, 2013.
Guidelines of 7 March 2013 on Good Distribution Practice of Medicinal Products for Human Use (2013/C 68/01)

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FDA Orange Book - New - Updated For 2011

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


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

- - - original post below - - -

There's been a lot of interest in the FDA's Orange Book by readers. Therefore, I'm pushing this information out to folks, so that they're aware.

It's here, the FDA's Orange Book 2011 - Approved Drug Products With Therapeutic Equivalence Evaluations 31st Edition (PDF). This volume is current through December 31, 2010.

If you want to search the Orange Book in other ways, go to the FDA's webpage, FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations.

Happy hunting!

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FDA Orange Book 2011 - It Just Arrived!

Updated April 16, 2019:
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 - - -

I've been watching and waiting for this to be released.

It's here, the FDA's Orange Book 2011 - Approved Drug Products With Therapeutic Equivalence Evaluations 31st Edition (PDF). This volume is current through December 31, 2010.

If you want to search the Orange Book in other ways, go to the FDA's webpage, FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations.

Happy hunting!

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FDA Orange Book - Most Current Versions

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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

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

- - - original post follows below - - -

The FDA ensures that the Orange Book data files are kept current. Every effort has been made to prevent errors and discrepancies in the Approved Drug Products data files.

You can go to this FDA page to find the latest versions of the Orange Book, FDA Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book). Included are the annual edition, supplements, and more,  for this publication that identifies drug products approved on the basis of safety and effectiveness by the Food and Drug Administration under the Federal Food, Drug, and Cosmetic Act.

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FDA Wants Your Input On Tobacco Regulation

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Updated March 2, 2020

The links in the original post broke.

You might also be interested in:
Tobacco Products - Rules, Regulations, and Guidance (on FDA.gov)

- - -  the original post follows below  - - -

The U.S. Food and Drug Administration (FDA) announced that it is seeking public input on the implementation of its historic new authority overseeing tobacco products in the United States. If you feel strongly about tobacco as I do, I hope you'll submit some feedback to the FDA.

More References:
The Federal Register Notice
FDA and Tobacco Regulation

Related Posts:
NPR On FDA Tobacco Oversight (audio)
Smoking Is Too Expensive - It is time to quit
e-Cigarettes In The News (video)
Fire Safe Cigarettes Are A Good Thing
3rd Hand Tobacco Smoke - A Danger To Your Loved Ones

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FDA Orange Book Online - Brand New Edition

• FDA GMP QSR cGMP Training - popular online training classes

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

- - - original post below - - -

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 Video Reassures Consumers - Peanut Products

Updated May 24, 2016 - The original video link broke. I've replaced it with something that might still interest you.

The U.S. Food and Drug Administration (FDA) wants to be clear with consumers as to what is safe and what should be avoided when it comes to peanuts and peanut products. David W.K. Acheson, M.D., Associate Commissioner for Foods at the U.S. Food and Drug Administration, talks about the current peanut butter recall and offers viewers a reassuring message about how to be careful with peanut products, in this FDA Responds to Peanut Butter Recall (video):

The replacement video comes from this FDA webpage, FDA - Food Allergies: What You Need to Know





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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. 

Previous Posts: The Health, Drug, Prescription, and GMP Supersite: New FDA Guidance - Residual Solvents in Drug Products 

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New FDA Guidance - New Contrast Imaging Indication Considerations

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The FDA has just released this new guidance document, "Guidance for Industry: New Contrast Imaging Indication Considerations for Devices and Approved Drug and Biological Products (pdf)." 

To get quickly up to speed on the gist of the guidance, read this commentary posted on the FDA Law Blog, "FDA Issues Contrast Imaging Draft Guidance; Implements Umbrella Approach to Imaging Device Labeling." 

In a nutshell, here's what the guidance covers . . . The guidance describes a process that allows either the imaging drug or imaging device developers to seek approval of medical imaging contrast indications using an already marketed imaging drug or biological product, including radiopharmaceuticals. 

 1. Device developers should generally submit a marketing application to add a new indication for using an already approved imaging drug under the circumstances described in this guidance. 1a. The data to establish these indications in a device application should include information developed in accordance with FDA existing guidance on Developing Medical Imaging Drug and Biological Products. 1b. For most types of indications as described in this guidance, when submitted to request marketing under a device application, the submission should be a Premarket Application (PMA). 

 2. Drug or biological product application holders of the already marketed imaging drug or biological product should generally submit an efficacy or labeling supplement, as appropriate, to add labeling for the new indication initially developed under a device application. 

 3. Device application holders may continue their current practice to request approval or clearance of labeling revisions for any new indications that may be initially approved in a supplement to the NDA for the imaging drug. 

 4. FDA expects to establish an internal intercenter imaging process to review and evaluate indications to ensure consistency in the development and review of clinical trials to establish the contrast indications that may be in either the drug or device labeling. 

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