Guidance on FDA 3988 and 3989

FDA has published a draft guidance, Annual Status Report Information and Other Submissions for Postmarketing Requirements and Commitments: Using Forms FDA 3988 and 3989, for use by applicants who are required by statute or regulation, or that have agreed in writing, to conduct post-marketing studies or clinical trials concerning a product’s clinical safety, clinical efficacy, clinical pharmacology, and nonclinical toxicology as postmarketing requirements or postmarketing commitments. The document describes the purpose and content of forms FDA 3988 and FDA 3989, when to use the forms, and how to submit them.

FDA says submission of FDA 3989 will meet the reporting requirements for postmarketing studies or clinical trials described in section 506B of the Federal Food, Drug, and Cosmetic Act and its implementing regulations.

The draft guidance does not apply to postmarketing studies or clinical trials that are not subject to the reporting requirements of section 506B.