What's New in Regulatory Science - Winter 2019

Brought to you by the Office of Translational Sciences (OTS) in collaboration with the Office of Communications (OCOMM) in the Center for Drug Evaluation and Research (CDER).   What’s New in Regulatory Science is a quarterly newsletter from the Food and Drug Administration’s Center for Drug Evaluation and Research. It includes new developments, opportunities, and initiatives in regulatory science, with the goal of advancing medical product development.   Please share this message and the sign-up link with colleagues, and if you have comments or questions, contact us at OTSCommunications@fda.hhs.gov.

HIGHLIGHT

STATE OF CDER 2019

Janet Woodcock, MD, CDER’s Center Director, delivered the State of CDER 2019 podcast, reflecting the accomplishments of the past year and priorities for 2019, including:

New Drug/Biologic Regulatory Program Modernization Drug Shortages

Compounding OTC Monograph User Fee Program Opioid Crisis

Download Podcast https://www.fda.gov/downloads/Drugs/NewsEvents/UCM630836.mp3 View Transcript: https://www.fda.gov/Drugs/NewsEvents/ucm630838.htm