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  1. Development & Approval Process (Drugs)

CDER Small Business and Industry Assistance (SBIA) Webinar: CDER Direct Electronic Submission Portal: 503B Product Reporting (Compounding)

CDER Small Business and Industry Assistance (SBIA) Webinar: CDER Direct Electronic Submission Portal: 503B Product Reporting (Compounding)

SBIA Webinar 2016

The Food and Drug Administration, Center for Drug Evaluation and Research and Small Business and Industry Assistance (CDER SBIA), invites you to our webinar series.

These events focus on a specific topic and provide an opportunity for small business and industry entities to learn more about the FDA and basic drug regulation. The webinars support CDER SBIA’s mission of promoting productive interaction with regulated industry by assisting small pharmaceutical business and industry with information relating to the development and regulation of human drug products.

CDER is making available the webinarCDER Direct Electronic Submission Portal: 503B Product Reporting (Compounding)” which introduces the FDA’s new web based tool called CDER Direct and presents a step-by-step demonstration of how to submit product reporting information for the 503B Outsourcing facilities using CDER Direct.

Speaker:

Paul Loebach
Lead Operations Research Analyst, Team Leader
Drug Registration and Listing System
Office of Compliance, CDER, FDA

For questions concerning the webinar, please contact CDER SBIA at:
(866)-405-5367 | (301)-796-6707

Presentation Information

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