Jenkins stepping down at FDA's Office of New Drugs

John Jenkins will step down as director of the Office of New Drugs (OND) at FDA’s Center for Drug Evaluation and Research (CDER) on January 6, the agency announced Monday.

During his 15 years leading OND, Jenkins has been responsible for designing and managing FDA’s review processes and for implementing numerous congressionally mandated innovations such as the biosimilars approval pathway, the breakthrough therapies program, and numerous expedited review initiatives...