NCRAF - US Legislation and the Resulting FDA Regulations/Guidances: The Odd Couple
Name:
NCRAF - US Legislation and the Resulting FDA Regulations/Guidances: The Odd Couple
Date:
October 24, 2019
Time:
5:30 PM - 7:30 PM EDT
Event Description:
David Shoemaker, Senior Vice President, Research and Development, Rho, Inc.
This talk will be a presentation of the speaker's perspective of the evolution of the U.S. regulatory environment over his 25+ year career in pharmaceutical product development. The impact of US legislation from the pre-PDUFA era to the current day on the development of regulations and guidances for drugs and biologics will be examined emphasizing the original intent of congress versus the ultimate result. Specific examples from the speaker's experience will be highlighted to demonstrate the development of his personal perspective of the changing U.S. regulatory environment including his current biases, suggested best practices, and anticipated trends for the future.
This talk will be a presentation of the speaker's perspective of the evolution of the U.S. regulatory environment over his 25+ year career in pharmaceutical product development. The impact of US legislation from the pre-PDUFA era to the current day on the development of regulations and guidances for drugs and biologics will be examined emphasizing the original intent of congress versus the ultimate result. Specific examples from the speaker's experience will be highlighted to demonstrate the development of his personal perspective of the changing U.S. regulatory environment including his current biases, suggested best practices, and anticipated trends for the future.
