Pro Pharma Talks

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, 3.5 yrs. 2. Vaccines a. Phase I fails = 37% b. Phase II fails = 69% c. Phase III fails = 42% d. Biologics License Application (BLA) application e. Vacc & Related Biologics Prod Adv Cmte (VRBPAC) 3. Risks a. New vaccine for new virus b. Clinical trials never succeed c. Vaccine induced enhancement d. Acquire study population ____ Make sure to subscribe to get the latest episode. Contact Us: Pharmacy Benefit News: http://www.propharmaconsultants.com/pbn.html Email: info@propharmaconsultants.com Website: http://www.propharmaconsultants.com/ Facebook: https://www.facebook.com/propharmainc Twitter: https://twitter.com/ProPharma/ Instagram: https://www.instagram.com/propharmainc/ LinkedIn: https://www.linkedin.com/company/pro-pharma-pharmaceutical-consultants-in