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Regulatory Focus™ > News Articles > 2020 > 10 > With new guidance, FDA moves toward uniform postmarketing reporting

With new guidance, FDA moves toward uniform postmarketing reporting

Posted 20 October 2020 | By Kari Oakes 

With new guidance, FDA moves toward uniform postmarketing reporting

A new draft guidance related to postmarketing requirements and commitments is available from the US Food and Drug Administration (FDA). 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 postmarketing requirements (PMRs) and postmarketing clinical trials (PMCs) if required to do so under section 506B of the Federal Food, Drug, and Cosmetics act (FD&C Act), or if PMCs are agreed upon by applicants and FDA.
In the Federal Register announcement of the draft guidance, FDA noted that electronic submission of the two forms is “expected to result in improved accuracy and timeliness of FDA’s identification and review of those submissions containing information on PMRs and PMCs.” The Government Accountability Office and the Health and Human Services’ Office of the Inspector General had previously recommended more uniform information be collected for the various annual status that are part of FDA’s postmarketing requirements, and that FDA maintain data in a more searchable and uniform format.
Excluded from the draft guidance are postmarketing studies that do not fall under the reporting requirements of section 506B of the FD&C Act, including voluntary studies and clinical trials or PMCs that study chemistry, manufacturing and controls (CMC) or to stability studies.
Draft version of the two forms, appended to the guidance, are not to be used until finalized. Form FDA 3988, when finalized, should be used to accompany PMR/PMC-related submissions and will allow standardized identification of the type of submission the applicant is making, and which PMR or PMC the submission is meant for. Form 3988 should not be used for annual status reports on PMRs and PMCs.
Form 3989 will be the form that applicants will use to provide annual status reports. Use of both forms is optional, but “FDA encourages their use because the forms should facilitate FDA management and review of the applicant’s submissions, as well as enhance the accuracy of data within FDA’s electronic document archiving systems,” said the agency. Both forms may only be submitted electronically.
Form 3989 is meant to replace company-derived status updates, clarified the agency: “In other words, applicants should not provide both a company-derived ASR on PMRs and PMCs and a completed Form FDA 3989 to this section of the annual report.”
The draft guidance provides detailed information on how to include form 3988 in the electronic common technical document (eCTD) for new drug applications, biologics license applications, investigational new drug applications and abbreviated new drug applications.
A glossary accompanies the guidance and gives in-depth definitions of terms, including definitions for the various possible PMR and PMS status categories.
Commentary on the draft guidance should be submitted by 21 December 2020.
Draft FDA guidance

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