Module 12 2019

Good Review Practices

As GRPs develop, review staff will adopt them into their daily review activities. Since GRPs can change and evolve frequently as a result of new science, statutes, regulations, guidances, and accumulated experience, the policies will be updated regularly.

Available here:

http://www.fda.gov/Drugs/GuidanceCompliance RegulatoryInformation/ucm118777.htm

The Organisation for Professionals in Regulatory Affairs