FDA Updates Bioequivalence Guidelines - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

FDA Updates Bioequivalence Guidelines


ePT--the Electronic Newsletter of Pharmaceutical Technology

Rockville, MD (Sept. 5)—The US Food and Drug Administration has updated its draft bioequivalence recommendations for several products, and added 66 new draft product-specific guidelines since October 2007. The drug products for which updated draft product-specific bioequivalence recommendations are available include: risedronate sodium, fosinopril sodium/hydrochlorothiazide, fluoxetine HCI/olanzapine, erlotinib HCI, and morphine sulfate.

In 2007, FDA announced in its draft guidance for industry, “Bioequivalence Recommendations for Specific Products,” that the agency was providing product-specific bioequivalence recommendations on its website to solicit public consideration and recommendations. The online process is intended to support drug manufacturers with abbreviated new drug applications.

Click here for the announcement of the new recommendations and here for the updated bioequivalence recommendations list. Comments on the updated recommendations can be made until Dec. 4, 2008.

ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
What role should the US government play in the current Ebola outbreak?
Finance development of drugs to treat/prevent disease.
Oversee medical treatment of patients in the US.
Provide treatment for patients globally.
All of the above.
No government involvement in patient treatment or drug development.
Finance development of drugs to treat/prevent disease.
23%
Oversee medical treatment of patients in the US.
14%
Provide treatment for patients globally.
7%
All of the above.
47%
No government involvement in patient treatment or drug development.
9%
Jim Miller Outsourcing Outlook Jim MillerOutside Looking In
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerAdvances in Large-Scale Heterocyclic Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler New Era for Generic Drugs
Sean Milmo European Regulatory WatchSean MilmoTackling Drug Shortages
New Congress to Tackle Health Reform, Biomedical Innovation, Tax Policy
Combination Products Challenge Biopharma Manufacturers
Seven Steps to Solving Tabletting and Tooling ProblemsStep 1: Clean
Legislators Urge Added Incentives for Ebola Drug Development
FDA Reorganization to Promote Drug Quality
Source: ePT--the Electronic Newsletter of Pharmaceutical Technology,
Click here