FDA´s Office of Regulatory Affairs restructured

Recommendation

23-25 April 2024

Cleaning Validation AND Pre-Course Workshop: Impact of Annex 1 Revision on Cleaning Validation - Live Online Training

The US Food & Drug Administration's main task is to protect public health. Therefore, the FDA has to keep pace with new developments in sciences and globalisation. To keep this pace and "to modernise and strengthen the FDA" the authority has set up an alignment programme.  This programme also changes FDA´s Office of Regulatory Affairs (ORA) structure. This means that ORA is getting a new structure. In the past, ORA was organised on a "management  structure based on geographic regions" in regional and district offices. Now, the new structure shall focus on product or operational offices. One of them, the Office of Pharmaceutical Quality Operations (OPQO) "coordinates, directs, and assists with pharmaceutical product investigative activities" e.g. GMP inspections.

For further information please also see the FDA Program Alignment and ORA site (including e.g., organisational charts, etc. ).