The draft guidance is being revised to describe the multiple factors that FDA considers, before requiring a postmarketing study or clinical trial for the purposes described in the Federal Food, Drug, and Cosmetic Act (FD&C Act), when determining the sufficiency of the reports under the FD&C Act and the active postmarket risk identification and analysis (ARIA) system available under the FD&C Act to meet these purposes.
This guidance provides information on the implementation of section 505(o)(3) of the FD&C Act (21 U.S.C. 355(o)(3)), which authorizes FDA to require certain postmarketing studies and clinical trials for prescription drugs approved under section 505(c) of the FD&C Act and biological products approved under section 351 of the Public Health Service Act (the PHS Act) (42 U.S.C. 262).
Read more online