FDA´s Office of Regulatory Affairs restructured
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. ).
Related GMP News
26.06.202410 points on how the FDA's CDER monitors the Quality of Medicinal Products
08.05.2024EMA Plans for the next three Years
30.04.2024Lean GMP: is "right-sizing" GMP and Compliance possible?
24.04.2024Unexpected Deviations: the Role of the QP
10.04.2024FDA's current Thinking on KPIs and Quality Metrics
21.02.2024What is the African Medicines Agency?