Regulatory News

FDA Quietly Announces Creation of New Regulatory Division, Search Begins for Leader

The US Food and Drug Administration (FDA) is looking to hire a high-level regulatory official to lead the agency's brand new division of Regulatory Affairs Strategic Management (RASM), it announced this week.

The position, for a deputy associate commissioner, was recently created "to respond to significant changes in the regulated industry" and FDA's scope of authority, the agency said in its job posting for the position.

Explained FDA:

"These changes include substantial increases in the number of products imported into the US as well as significant increases in the complexity of products regulated, especially medical devices.  In the last few years, FDA's  responsibilities have significantly expanded through enactment of Tobacco legislation, Food Safety legislation and Generic Drug legislation, just to name a few.  As a result, FDA is reexamining how to perform its regulatory responsibilities in the most efficient and effective way.   Nowhere in FDA are these challenges more real than how the ORA resources are used."

The position would "lead all of [the Office for Regulatory Affairs' (ORA)] strategic management responsibilities," it added, and take charge of approximately 350 ORA staff members.

Duties will include strategic planning, risk-based resource allocation, designing long-term work plans, working with FDA product centers to integrate needs, and "designing a change management program for the field to meet the ever increasing needs for specialization in the ORA workforce."

The new division, RASM, appears to be a part of the ORA overhaul announced in February 2014. At the time, FDA said it wanted its regulatory programs to become more "vertically-integrated" and be characterized by "coherent policy and strategy development."

FDA Job Posting for DACRA SM