FDA Premarket Approval: Process of Approving Ansaid as a Drug

Pursuant to a congressional request, GAO reviewed the Food and Drug Administration's (FDA) process for granting premarket approval for a nonsteroidal, anti-inflammatory drug primarily sold to treat arthritis symptoms, focusing on: (1) whether the manufacturing company delayed preparing and submitting its new drug application; and (2) the company's allegations that the FDA approval process period was excessive.