Guidance on Annual Status Reports of Postmarketing Studies

FDA published guidance on Oct. 20, 2020 for applicants required to annually report the status of postmarketing studies and clinical trials concerning a product’s clinical safety, clinical efficacy, clinical pharmacology, and nonclinical toxicology as postmarketing requirements (PMRs) or postmarketing commitments (PMCs) under section 506B of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and 21 Code of Federal Regulations (CFR) 314.81(b)(2)(vii) and 601.70.

The guidance explains when and how to submitFDA 3988, Transmittal of PMR/PMC Submissions for Drugs and Biologics, and Form FDA 3989, PMR/PMC Annual Status Report for Drugs and Biologics. The guidance stresses that these forms do not replace existing requirements to submit other FDA forms and “are not intended to accompany or replace any submissions related to postmarketing studies or clinical trials that are not subject to the reporting requirements of section 506B of the FD&C Act.”

“The guidance does not apply to voluntary studies or clinical trials conducted by an applicant or on an applicant’s behalf that are neither required nor agreed upon in writing. This guidance also does not apply to PMCs related to chemistry, manufacturing, and controls or stability studies,” the guidance states.