The FDA issued a draft guidance regarding its postmarketing requirements (PMRs) and commitments. The document details how drug and biologics marketers will use two forms for online submission of annual status report and other required postmarketing information. The forms, FDA 3988 and 3989, are the mechanisms by which applicants will fulfill requirements for annual reporting on the status of PMRs and postmarketing clinical trials (PMCs) if required to do so under section 506B of the Federal Food, Drug, and Cosmetics act, or if PMCs are agreed upon by applicants and FDA.
Guidance
The new guidance outlines the ways in which drug and biologic marketers can use forms FDA 3988 and 3989 for submitting annual status reports and other postmarketing information online. Additionally, the document provides information on how to include the forms in the electronic common technical document (eCTD) for new drug applications, biologics license applications, investigational new drug applications and abbreviated new drug applications.
According to the FDA, Form FDA 3988 should accompany each PMR/PMC-related submission, including any submission related to PMR and PMC draft and final protocols, interim reports, final reports, general correspondence, requests for Pediatric Research Equity Act deferral extensions, responses to information requests, and revised milestone requests. When submitted, the form should be included on the eCTD in the “Forms” section or, if the applicant’s eCTD publishing tool does not include such a section, in the “Cover Letter” section.
Form FDA 3989 can be used to replace the Status of Postmarketing Study Commitments and Requirements content in the eCTD. Further, the annual submission of Form FDA 3989 will meet the reporting requirements for postmarketing studies or clinical trials described in Section 506B of the FDCA. If an applicant chooses to use the form, the applicant should submit it instead of adding a company-derived status update document in the eCTD. Additionally, if opting to submit Form FDA 3989, applicants must complete Form FDA 2252 as well.
The FDA noted that while the use of these forms is entirely optional, applicants must submit them electronically if they choose to use them. Furthermore, the agency stressed that providing complete and accurate information on the forms will help expedite routing of submission for FDA review and any follow-up.