What you need to know about the FDA’s proposed new PMR/PMC forms
In October 2020, FDA released a draft guidance indicating that they will be encouraging the use of new forms FDA 3988 and FDA 3989 to improve the agency’s collection, identification, and use of information regarding PMRs (post marketing requirements) and PMCs (post marketing commitments). The implementation date is still to be determined. Once the guidance goes into effect, you should expect to complete and submit the new forms as part of your PMR/PMC-related submissions.
What are PMRs and PMCs?
PMRs and PMCs are studies or clinical trials (concerning clinical safety, clinical efficacy, clinical pharmacology, or nonclinical toxicology) conducted by the applicant after FDA has approved a drug or biologic product for marketing or licensing. These studies or clinical trials can be either required by statute or regulation (in the case of PMRs) or agreed upon in writing by the FDA and the applicant as part of the application process (PMCs).
Why is the FDA Adding Forms to the PMR/PMC Submission Process?
Information submitted in sponsors’ Annual Status Reports (ASR) on PMRs and PMCs is reviewed for accuracy and used by the agency for monitoring, tracking, and oversight of PMRs and PMCs and for maintaining their internal databases and public web page. The use of the new forms should minimize manual data entry by FDA staff and thereby improve the speed and accuracy of the agency’s data collection and reporting. For more information, see FDA’s related web pages, starting with “Postmarketing Requirements and Commitments: Introduction”.
Why two new forms?
Form 3988 is for submission with any PMR/PMC documentation you are sending except for Annual Status Reports (ASRs). Form 3989 is to be submitted only with your ASRs. This two-form system – one for most submissions, another only sent with yearly required reports – echoes what the FDA already expects from companies who use form 356h for many electronic common technical document (eCTD) submissions but replace it with form 2252 exclusively for their NDA, ANDA, or BLA annual reports.
Do the new forms replace forms or documents we’re already submitting?
Form 3988 will be added to the PMR/PMC documentation you’re submitting. PMR- and PMC-related submission types that this form will accompany will include:
- Draft protocol
- Final Protocol
- Interim Report
- Final Report
- General Correspondence
- Pediatric Research Equity Act (PREA) PMR Deferral Extension Request
- Response to Information Request
- Request for Revised Milestones
Correctly filling out Form 3988 will help the FDA to properly categorize your PMR/PMC submission.
Form 3989 will work a little differently in that the FDA asks you to use it to replace ASR information that would previously be included in a company-derived document in eCTD section 1.13.12 (“Status of Postmarketing Study Commitments and Requirements.”) The FDA prefers you use this form instead of any custom document in that section.
It’s important to note that in both cases, the main form required for electronic submissions gateway (ESG) transmission – 356h for most submissions, 2252 for Annual Reports – must still be included along with the new forms 3988 and 3989. For NDA/ANDA ASR submissions, FDA recommends that any company filling out section g. “Status Reports of Open PMRs/PMCs” on their Form 2252 refer to the accompanying Form 3989. BLA holders will still check the box for “Annual Progress Reports of Postmarketing Studies.” For BLAs, the ASR on PMRs and PMCs is a separate submission from the BLA Annual Report; the Form 2252 is required for both reports.
Can you summarize the differences between the new forms?
|Form FDA 3988||Form FDA 3989|
|Name||Transmittal of PMR/PMC Submissions for Drugs and Biologics||PMR/PMC Annual Status Report for Drugs and Biologics|
|Purpose & Content||Provide PMR/PMC-related information for all PMR/PMC submissions except the Annual Status Report (ASR)||Replace content previously included in eCTD section 1.13.12 (“Status of Postmarketing Study Commitments and Requirements”)|
|When to Use||Accompany all PMR/PMC-related submissions except the Annual Status Report (ASR)||Accompany the ASR|
|How to Submit||Include in section 1.1 (Forms) of the eCTD sequence if possible or section 1.2 (Cover Letter) section of the eCTD if section 1.1 for Form 3988 is not yet supported||Include in section 1.13.12 of the eCTD sequence, in place of any company-derived status update document. Form 2252 is still required with submission of annual report|
Reach out to our team of regulatory and submissions experts if you have any questions about when, how, or why you should be using the new FDA forms 3988 and 3989. Also see this blog post for best practices for completing FDA forms, in general.