Upcoming CDER Webinar on E-submissions – Monday, February 9th
On February 9, 2015 at 11 am (EST), CDER will host a webinar titled: "The Requirements to Provide Regulatory Submissions in Electronic Format – Standardized Study Data."
The featured speakers will be Mary Ann Slack, Deputy Director and Ron Fitzmartin, PhD, MBA. Senior Advisor, Office of Strategic Programs, Center for Drug Evaluation and Research (CDER).
The webinar will provide an overview of the final guidances and related technical specifications that implements the electronic submission requirements of section 745A(a) of the FD&C Act for study data contained in new drug applications (NDAs), abbreviated new drug applications (ANDAs), biologics license applications (BLAs), and investigational new drug applications (INDs).
For more information: http://www.fda.gov/Drugs/
The Small Business and Industry Assistance program in the Center for Drug Evaluation and Research (CDER SBIA) provides guidance and information to regulated domestic and international small pharmaceutical business and industry 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 CDER SBIA staff. If you have comments or questions, please contact us Monday through Friday 8:00AM - 4:30PM.
- Email: CDERSBIA@fda.hhs.gov
- Phone: 1-866-405-5367
- Phone: (301) 796-6707
- Website: http://www.fda.gov/cdersbia
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