FDA Takes Steps to Improve Efficiency of PMR/PMC Submissions
The Food and Drug Administration (FDA) has released draft guidance for industry on the use of new Forms FDA 3988 and FDA 3989 to submit information on post-marketing requirements (PMRs) and post-marketing commitments (PMCs). The new forms are intended to facilitate submissions by drug and biological product application holders of complete and accurate information in a consistent format.
PMRs and PMCs
PMRs and PMCs are studies or clinical trials conducted by the applicant after FDA has approved a drug or biologic product for marketing or licensing. PMRs are required by statute or regulation, while PMCs are agreed upon in writing by the FDA and the applicant as part of the application process.
PMRs and PMCs are important for ensuring the safety and efficacy of drugs and biologic products after they are marketed. They can be used to collect additional data on the product’s safety and efficacy, to identify and mitigate potential risks, and to develop new information about how to use the product safely and effectively.
New Forms 3988 & 3989
Form FDA 3988, Transmittal of PMR/PMC Submissions for Drugs and Biologics, is intended to be used to submit all PMR/PMC-related documentation, except for Annual Status Reports (ASRs). Form FDA 3989, PMR/PMC Annual Status Report for Drugs and Biologics, is intended to be used to submit ASRs.
The new forms are designed to be more user-friendly and efficient than the existing forms. They include predefined fields for applicants to complete, which will help to ensure that the FDA receives complete and accurate information.
Implementation Timeline
The FDA has not yet announced a date for implementing the new forms. However, the agency is encouraging applicants to begin familiarizing themselves with the new forms and to start using them as soon as possible.
Implications for Applicants
Applicants should review the draft guidance carefully and start preparing to use the new forms. The guidance provides detailed instructions on how to complete the forms and includes examples of submissions.
Applicants should also be aware that the new forms are not required until the FDA finalizes the guidance. However, using the new forms early will help to ensure that applicants are prepared for the implementation date and that their submissions are complete and accurate.
The FDA’s draft guidance on the use of new Forms FDA 3988 and FDA 3989 is a welcome development for drug and biologic product application holders. The new forms are designed to be more user-friendly and efficient, and they will help the FDA to receive complete and accurate information on PMRs and PMCs.
Applicants should review the draft guidance carefully and start preparing to use the new forms. Using the new forms early will help to ensure that applicants are prepared for the implementation date and that their submissions are complete and accurate.
If you are a drug or biologic product application holder, you need to be prepared to use the new Forms FDA 3988 and FDA 3989 to submit PMR/PMC information. Contact us today to learn more about how we can help you with your PMR/PMC submissions.
