Postmarketing Requirements and Commitments: Using Forms FDA 3988 and FDA 3989 Guidance for Industry

The FDA published the final guidance on annual status reports and other submissions for postmarketing requirements (PMRs). The reports are intended to facilitate submissions by drug and biological product application holders of complete and accurate information on PMRs and postmarketing commitments (PMCs) in a consistent format. These forms are expected to result in improved accuracy and timeliness of FDA’s identification and review of those submissions containing information on PMRs and PMCs. The guidance covers

the purpose of each form,

when to use these forms,

how to submit these forms.

The guidance also explains where applicants will be able to find the forms and instructions.

Background

Applicants are required to provide the agency with an annual report on the status of each PMR and PMC conducted to assess clinical safety, clinical efficacy, clinical pharmacology, or nonclinical toxicology of a human drug and biological product until FDA notifies the applicant, in writing, that the PMR or PMC has been fulfilled or that the PMR or PMC is no longer feasible or would no longer provide useful information.

This annual status report (ASR) on PMRs and PMCs must include the progress of the PMR or PMC or the reasons for failing to conduct the requirement or commitment. The specific milestone dates set forth as part of a PMR / PMC for conducting and completing a PMR / PMC include the following:

Draft protocol submission date

Final protocol submission date

Study/clinical trial completion date

Final report submission date