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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Drugs (OGD) has published the final version of the ANDAs: Stability Testing of Drug Substances and Products, and a draft Guidance that follows the stability guidance as ‘Questions and Answers’ relating to the Stability topic for generic drug applications.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/sba110413/event/registration.html (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.fda.gov/sba110413/event/registration_login.html Audio will broadcast from your computer speakers. If you experience technical difficulties email Jeffery.Rexrode@fda.hhs.gov for assistance. Closed captioning will be provided. Questions/Comments can be submitted live via a Q/A chat window. For More Information: http://www.fda.gov/smallbusinessdrugs Click on Workshops and Webinars in Spotlight box If you've never used Connect Pro, get a quick overview: http://www.adobe.com/go/connectpro_overview Test your connection prior to the day of the event: https://collaboration.fda.gov/common/help/en/support/meeting_test.htm Adobe, the Adobe logo, Acrobat and Acrobat Connect are either registered trademarks or trademarks of Adobe Systems Incorporated in the United States and/or other countries.
The Small Business Assistance (SBA) program in the Center for Drug Evaluation and Research (CDER) provides guidance and information to regulated domestic and international small pharmaceutical business through its website, email notifications, and workshops. This notification system provides current information from CDER/FDA via e-mail on a biweekly basis that is relevant to small pharmaceutical business, which includes Federal Register notices, guidances, workshop announcements, etc. This is an automated message delivery system. Replying to this message will not reach the SBA staff. If you have comments or questions, please contact us Monday through Friday 8:00AM – 4:30PM. Please take our CDER Small Business survey: https://www.surveymonkey.com/s/cdersmallbusiness
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