Enforcement Trends: CDER Presentation Confirms Fewer Warning Letters Are Issued by FDA for OAI Inspections
FDA Law Blog: Biosimilars
AUGUST 14, 2023
Farquhar — At the GMP by the Sea Conference ongoing in Cambridge, Maryland, a presentation was made by a representative of FDA’s Center for Drug Evaluation and Research that shows some interesting trends in enforcement. By Douglas B. OAI is FDA’s classification for facilities it deems to be in an unacceptable state of compliance.
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