The QMN Weekly Bulletin
Pharmaceuticals / Regulatory Affairs / Inspections and Audits

ORA Making Progress on Program Alignment

Jan. 29, 2016
A A

The FDA’s Office of Regulatory Affairs is making progress on its new program alignment and released information on what the new structure will look like.

The new ORA will consist of six offices — pharmaceutical quality operations, biologics operations, medical device operations, bioresearch monitoring operations, tobacco operations and human and animal foods.

Pharmaceutical quality operations will be led by Alonza Cruse, the current director of the FDA’s Los Angeles District Office, and will consist of four management teams. Staff will remain in district offices but will have different reporting lines. Biologics and BIMO will each have two management teams, while devices will have three, said Douglas Stearn, director of the Office of Enforcement & Import Operations.

The program alignment will see district offices focus on only one category of product, designated by geographic location, Stearn said at a Dec. 10, 2015 session of the Food and Drug Law Institute’s Enforcement, Litigation and Compliance conference in Washington, D.C.

The initiative was announced a year ago, and while the planning phase has largely been completed, the agency hopes to move into the implementation phase over the next year or two.

There will be eight major benefits of program alignment, Stearn said. It will help the agency establish commodity-based and vertically integrated regulatory programs, increase specialization, enhance employee training, revamp the agency’s work planning, improve compliance policy and enforcement strategies, enhance import operations, advance laboratory optimization and address ORA streamlining.

Stay up to date on regulatory stories like this one by subscribing to the Drug GMP Report. For over 20 years, drug manufacturers have relied on DGR for the latest on FDA’s interpretation and enforcement of cGMPs and the Quality Systems Regulation — information you need to stay in compliance.