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: [email protected]

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-inc/

Podcast: https://anchor.fm/pro-pharma-talks

Podden och tillhörande omslagsbild på den här sidan tillhör Pro Pharma. Innehållet i podden är skapat av Pro Pharma och inte av, eller tillsammans med, Poddtoppen.