Pro Pharma Talks
Corona Virus Vaccine & The FDA Process
September 16, 2020
PP Talks -- Is It Common for Compounds to Fail the FDA Approval Process?
1. Stages of FDA Approval Process IND
a. Phase 1 – Safety – 20-100 healthy, 2 yrs.
b. Phase 2 – Effectiveness – 100-500 patients, 2 yrs.
c. Phase 3 – Effectiveness & ADR, 1K-5K,
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