miércoles, 10 de diciembre de 2014

CDER SBIA Update: Draft Guidance and Webinar - DSCSA Implementation - Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers

FDA/CDER's Small Business and Industry Assistance (CDER SBIA)

Draft Guidance for Industry on
Drug Supply Chain Security Act Implementation: Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers

Today FDA announced the availability of a new draft guidance describing the Agency’s annual reporting procedures for prescription drug wholesale distributors and third-party logistics providers as required under the supply chain provisions of the Drug Quality and Security Act.
The draft guidance, Drug Supply Chain Security Act Implementation: Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providersoutlines the information that should be submitted to FDA, the timing of the submissions, a preferred format for the submissions, and a preferred method for reporting to FDA. 
CDER Small Business and Industry Assistance will produce a webinar covering this guidance and annual reporting requirements on December 16, 2014. The webinar will be available via the CDER SBIA web page.
Annual reporting by third-party logistics providers and wholesale distributors can be made using FDA’s CDER Direct Electronic Submissions Portal.
Last month, FDA also published the draft guidance on DSCSA Standards for the Interoperable Exchange of Information for Tracing of Human, Finished Prescription Drugs:  How to Exchange Product Tracing Information, to assist manufacturers, repackagers, wholesale distributors and dispensers to comply with the new product tracing requirements.
For more information about DSCSA implementation and new requirements to develop and enhance drug distribution security, please visit FDA’s Drug Supply Chain Security Act web page.



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.
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