
Guidance on Annual Status Reports of Postmarketing Studies
FDA issued guidance for applicants that must report annually on the status of postmarketing studies and clinical trials under section 506B of the FD&C Act.
FDA published
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.
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