The Small Biz Buzz
The Information Source for Regulated Domestic and International Small Pharmaceutical Business
The Information Source for Regulated Domestic and International Small Pharmaceutical Business
CDER
Small Business Webinar on Stability Guidance for ANDAs, and draft
Questions and Answers guidance – considerations – November 4, 2013
On Monday November 4, 2013, at 2 PM ET, the CDER Small Business Assistance Program will present 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Drugs (OGD) has published the final version of the ANDAs: Stability Testing of Drug Substances and Products, and a draft Guidance that follows the stability guidance as ‘Questions and Answers’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 will serve to address any resulting
questions and concerns.
The
stability guidance will be implemented on June 20, 2014 and the goal of
this webinar is 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)
will present and clarify stability data and required information.
To register for this Event, please go the following link: https://collaboration.fda.gov/
(Registration password needs to be 8 characters and alphanumeric )
Guidance Webinar Online - Access Instructions (there is no call in access):
After you register, to access this webinar, please go to the following link: https://collaboration.
Audio will broadcast from your computer speakers.
If you experience technical difficulties email Jeffery.Rexrode@fda.hhs.gov
Questions/Comments can be submitted live via a Q/A chat window.
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