Module 1 2021

How does FDA achieve its mission?

• For prescription drug/biologics products:  IND regulatory process  NDA/BLA regulatory process  Post-marketing surveillance of drug safety

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Scope of Products Regulated

• Drugs (Prescription and Over-The-Counter) • Biologics − Vaccines − Blood products − Biotechnology products, cell products, and gene therapy • Medical Devices • Food • Veterinary products • Consumer and Medical Radiation Products • Cosmetics

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