Janet Woodcock new FDA Acting Commissioner

Recommendation

13/14 December 2023
Berlin, Germany

Root Cause Analysis
A CAPA Workshop on Successful Failure Investigation

When the new US President Biden took office, the previous FDA Commissioner Stephen M. Hahn resigned from his position. On January 20, 2021, Dr Janet Woodcock was named Acting Commissioner.

Dr Woodcock has had a long career at the FDA, including being Director of the FDA's Center for Drug Evaluation and Research (CDER). "There she led many of the FDA's drug initiatives, including introducing the concept of risk management as a new approach to drug safety; modernizing drug manufacturing and regulation through the Pharmaceutical Quality for the 21st Century Initiative; advancing medical discoveries from the laboratory to consumers more efficiently under the Critical Path Initiative; and launching the Safety First and Safe Use initiatives designed to improve drug safety management within and outside the FDA, respectively".

"As Acting Commissioner, Dr. Woodcock oversees the full breadth of the FDA portfolio and execution of the Federal Food, Drug, and Cosmetic Act and other applicable laws. This includes assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices; the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation; and the regulation of tobacco products."

Source: FDA Website