Postmarketing Safety Reporting for Combination Products

OMB 0910-0834

OMB 0910-0834

For combination products for which the constituent parts receive marketing authorization under separate applications held by different entities, the Agency established a requirement, specific to these “constituent part applicants,” that they must share safety information they receive related to certain events with the other constituent part applicant(s), and maintain records of this information sharing.

The latest form for Postmarketing Safety Reporting for Combination Products expires 2023-10-31 and can be found here.

OMB Details

Submitting various reports

Federal Enterprise Architecture: Health - Consumer Health and Safety


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