Concept

Accelerated approval

FDA pathway for drugs for serious conditions, allowing approval on a substitute measure of benefit, with later confirmation.

2 links, 2 backed by primary records

Connections 2

U.S. Food and Drug Administration According to U.S. Food and Drug Administration Primary record 1
FDA's own history says the 1988 protest pushed it to write the accelerated approval rules.

Proof 1 source

The History of FDA's Role in Preventing the Spread of HIV/AIDS, U.S. Food and Drug Administration. Primary record
pushed FDA to promulgate new accelerated approval regulations to accompany new treatment regulations for Investigational New Drugs implemented in 1987

Page history 1 change