Annual Status Report Information and Other Submissions for Postmarketing Requirements and Commitments
This guidance is intended for applicants that are required to report annually on the status of postmarketing studies and clinical trials for human drug and biological products under section 506B of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 356b) and its implementing regulations at 21 CFR 314.81(b)(2)(vii) and 601.70. In other […]
Availability of FSIS Import Guidance
In July 2017, FSIS published and requested comment on guidance for importing meat, poultry, and egg products into the United States. FSIS is announcing updates to this guidance and responding to comments received on the guidance. FSIS intends for this guidance to help U.S. importers, customs brokers, official import inspection establishments, and other interested persons […]