Figure 1.
The evolution of evidence requirements for new drugs and devices, 1960–2020. ANDA, abbreviated new drug application; PMA, premarket approval application; PDUFA, Prescription Drug User Fee Act; MDUFA, Medical Device User Fee Act.
Official websites use .gov
A
.gov website belongs to an official
government organization in the United States.
Secure .gov websites use HTTPS
A lock (
) or https:// means you've safely
connected to the .gov website. Share sensitive
information only on official, secure websites.