The Food and Drug Administration, Center for Drug Evaluation and Research (CDER) Small Business Assistance Program is pleased to inform you of a unique opportunity for small business entities to learn more about the FDA and basic drug regulation. Our webinar series highlights various aspects of drug regulation.
These focused webinars support the Program’s mission of promoting productive interaction with regulated industry by assisting regulated domestic and international small pharmaceutical business with information relating to the development and regulation of human drug products.
On Monday April 8, 2013, the CDER Small Business Assistance Program presented a webinar entitled What's New with the 356h Form?
This Webinar acquainted participants with recent changes that have been made to FDA Form 356h which accompanies all regulatory submissions associated with New Drug Applications (NDAs), Biologic License Applications (BLAs), Abbreviated New Drug Applications (ANDAs), and supplements to approved applications. We provided an overview of the changes that were made and then walked participants through the various fields of the form, populated with mock-data, while providing instructions as to what information is to be captured in each field. Time for questions from participants were allotted at the end of the Webinar.
Our presenter was Beth Duvall who is the Associate Director for Regulatory Affairs in the Office of New Drugs Immediate Office (OND IO) in the Center for Drug Evaluation and Research (CDER), FDA. In her position, Beth manages the Regulatory Affairs Team (RAT) in OND IO that is responsible for implementing and overseeing 21st Century Review processes and PDUFA V provisions, including the Enhanced Communications Team and Breakthrough Therapy designation requests, and for providing support and oversight for the DARRTS Program, Formal Dispute Resolution, OND Process Improvements, and other cross-cutting initiatives within CDER. Ms. Duvall earned a B.S. Degree in Chemistry (minor in mathematics) from the University of Delaware.
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