From The Corner Lab - Blog Posts

FDA Publishes Q&A on Draft Guidance - ANDAs: Stability Testing of Drug Substances and Products

Posted by Jim Menoutis on Mon, Sep 09, 2013 @ 10:15 AM

FDA published its long awaited draft guidance for industry, ANDAs: Stability Testing of Drug Substances and Products, Questions and Answers, in the Federal Register August. 27, 2013. The document provides answers to questions submitted during the public comment period on the draft stability guidance that was published on September 25, 2012. The final guidance for industry was published on June 20, 2013. The question-and-answer draft guidance document is open for comment for the next 60 days.

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Topics: DMF, Drug Master File, Drug Substance, Drug Product, Generic Drug, ICH Stability Guidlines, FDA ANDA Guidance, CDER, OGD, Office of Generic Drugs, Stability Testing

FDA Adopts ICH Standards for Generics Stability Testing Involving ANDAs

Posted by Jim Menoutis on Mon, Jul 08, 2013 @ 03:55 PM

The US Food and Drug Administration (FDA) has released a new  2 page guidance for industry that pertains to stability  testing recommendations for generic drug products submitted under 505(j) of the Federal Food, Drug and Cosmetic Act (FD&C Act) as an abbreviated new drug application (ANDA) or a drug master file (DMF).

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Topics: Generic Drug, ICH Stability Guidlines, FDA ANDA Guidance, CDER, OGD, Office of Generic Drugs