Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Postmarketing Adverse Experience Reporting
Published Date: 1/17/2025
Notice
Summary
The FDA is updating how drug companies report problems people have after using their medicines. This helps keep medicines safe by making sure the FDA gets clear, timely info. Drug makers need to follow new rules and send comments by February 18, 2025, but there’s no big cost change expected.
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Analyzed Economic Effects
6 provisions identified: 0 benefits, 6 costs, 0 mixed.
Mandatory Electronic Adverse Event Reports
If you manufacture, pack, distribute, or sponsor drugs or biologics, all adverse experience reports and followup reports must be submitted to FDA in electronic format (via the Electronic Submissions Gateway or the Safety Reporting Portal). Waivers of the electronic requirement may be granted for good cause.
Large Estimated Increase in Paperwork Burden
FDA reports the total burden hours for this information collection have increased by 61,614,921 hours and 2,546,112 responses compared to the previous renewal; current total estimated annual reporting hours are 51,690,702 and recordkeeping hours are 24,627,827.8. FDA also estimates operating and maintenance costs of approximately $25,000 (reporting) and $22,000 (recordkeeping) annually.
Long Recordkeeping Timeframes Required
Manufacturers, applicants, packers, and distributors must keep records of adverse drug experience reports for long periods: 10 years for prescription drug applicants and manufacturers (21 CFR 314.80(j) and 310.305(g)) and 6 years for nonprescription (OTC) drug adverse event records under section 760(e).
15-Day Alerts and Periodic Reporting Deadlines
Applicants must send 15-day 'Alert' reports for serious, unexpected adverse drug experiences (Sec. 314.80(c)(1)(i)) and must submit periodic safety reports quarterly for the first 3 years after U.S. approval and annually thereafter (Sec. 314.80(c)(2) and 600.80(c)(2)).
OTC Products Included in Reporting Rules
Over-the-counter (OTC) drug products marketed without an approved application — including products under the OTC Drug Monograph Review process or marketed outside the monograph system — are required to submit adverse event reports in electronic format under section 760 and related regulations (Sec. 329.100).
5-Day Notice Rule for Combination Products
For combination products that include a drug, if an event involves death, serious injury, or an adverse event and the product sponsor receives the information, the sponsor must provide that information to the other constituent part applicant(s) no later than 5 calendar days after receipt (21 CFR 4.103).
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