FDA to Give Industry Heads Up on Finalizing Q&A Guidance on Stability Testing for ANDAs

With about one month to go before the Office of Generic Drugs (OGD) new stability requirements go into effect, a one hour briefing by invitation will be held on May 15, 2014 to discuss the new requirements.  It will likely touch on the Draft Questions and Answers Guidance ANDA: Stability of Drug Substance and Drug Products, with (hopefully) an emphasis on any clarifications or revisions that have been made to the final guidance (to be published soon).   

The FDA stated in their e-mail:

FDA will finalize the question-and-answer guidance for industry covering stability testing for Abbreviated New Drug Applications. You are invited to a one-hour media briefing with representatives from the FDA’s Center for Drug Evaluation and Research to receive more information about this document. The briefing will be from 10:00a.m.-11:00a.m. on Thursday, May 15, 2014, and you will have the opportunity to ask questions during at this time. You MUST RSVP to CDERTradePress@fda.hhs.gov, at which time, we will send you more information and the call-in numbers if you are unable to attend in person.

We don’t know if the space is limited for this briefing but we will hopefully attend and will provide a summary of any salient points raised during the briefing or from the questions raised by the audience (if FDA has answers).