Federal Register #FDA-2026-N-3098

FDA Requests Public Comment on Postmarketing Adverse Experience Reporting Information Collection

This notice from the Food and Drug Administration (FDA) seeks public comment on proposed information collection for postmarketing adverse experience reporting for drugs and biological products. - Government Buyer: - Food and Drug Administration (FDA), Department of Health and Human Services - Scope of Information Collection: - Applies to manufacturers, packers, distributors, and applicants of drug and biological products - Requires reporting of serious, unexpected adverse drug experiences - Includes follow-up reports and periodic safety reports - Reporting Requirements: - Electronic submission of reports is mandatory, with waivers available for good cause - Recordkeeping requirements: - 10 years for prescription drugs - 6 years for nonprescription drugs - Compliance with regulations: 21 CFR part 4, 310.305, 314.80, 314.81, 314.98, and 329.100 - Unique/Notable Requirements: - No specific OEMs or vendors involved; this is an information collection request - Supports FDA's ongoing postmarketing drug safety monitoring - Emphasizes electronic submission standards and long-term record retention

Description

The Food and Drug Administration (FDA) is seeking public comment on the proposed collection of information related to postmarketing reporting and recordkeeping of adverse experiences for drug and biological products. This includes reporting serious, unexpected adverse drug experiences, follow-up reports, and periodic safety reports. The collection supports FDA's monitoring of drug safety postmarketing and requires electronic submission of reports, with waivers available for good cause. Comments on this information collection are requested to improve the process and ensure compliance with regulatory requirements.

View original listing