Pre-Approval Inspections: What to Expect When Being Inspected (15of15) REdI – May 29-30, 2019

Sean Marcsisin from the FDA Office of Regulatory Affairs explains the pre-approval inspectional process. He discusses what triggers an inspection, items that are evaluated during an inspection, and common pre-approval inspectional concerns.

Learn more at https://www.fda.gov/drugs/cder-small-...


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