CDER Small Business Webinar on Stability Guidance for ANDAs, and draft Questions and Answers guidance – considerations – November 4, 2013

The Food and Drug Administration, Center for Drug Evaluation and Research (CDER) Small Business Assistance Program is pleased to inform you of a unique opportunity for small business entities to learn more about the FDA and basic drug regulation. Our webinar series highlights various aspects of drug regulation.

These focused webinars support the Program’s mission of promoting productive interaction with regulated industry by assisting regulated domestic and international small pharmaceutical business with information relating to the development and regulation of human drug products.
On Monday November 4, 2013, the CDER Small Business Assistance Program presented a webinar entitled Stability Guidance for ANDAs, and draft Questions and Answers guidance – considerations.
FDA’s Office of Generic Drugs (OGD) has published the final version of the ANDAs: Stability Testing of Drug Substances and Products, and a draft Guidance that follows the stability guidance as ‘Questions and Answers’ relating to the Stability topic for generic drug applications. The Agency hopes that this webinar served to address any resulting questions and concerns.
The stability guidance will be implemented on June 20, 2014 and the goal of this webinar was to provide additional information that will assist in the ease of adoption of the International Conference on Harmonisation (ICH) recommended stability guidances for the submission of ANDAs to OGD. Two FDA Lead Chemists (Drs. Suhas Patankar and Radhika Rajagopalan) presented and clarified stability data and required information. 
Speakers (click names for bios):

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