CDER Small Business and Industry Assistance > CDER SBIA Webinar - Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers - December 16, 2014

CDER Small Business and Industry Assistance > CDER SBIA Webinar - Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers - December 16, 2014

CDER SBIA Webinar - Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers

On December 9th, 2014 FDA published a notice in the Federal Register (FR) announcing the availability of the“DSCSA Implementation: Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers – Draft Guidance for Industry”.

  

CDER SBIA is making available its accompanying pre-recorded webinar which:

- provides an overview of the reporting requirements for wholesale distributors and third-party logistics providers under DSCSA

- describes who must report to FDA,

- what information should be submitted to FDA,

- the timing of the submissions,

- a preferred format for the submissions, and

- a preferred method for reporting to FDA.

Please refer to CDER SBIA Webinar - Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers - December 16, 2014 and the DSCSA web page 

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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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CDER Small Business and Industry Assistance > CDER SBIA Webinar - Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers - December 16, 2014