FDA Finalizes Guidance on Postmarketing Safety Reporting for Combination Products
The FDA outlined the ways companies are expected to comply with postmarketing safety reporting (PMSR) requirements for combination products in final guidance.
The 44-page guidance goes in depth on the numerous types of combination product PMSR reports, what information should be included in them, and hypothetical scenarios to help companies understand them better.
“Serious” and “unexpected” adverse events in combo products containing a drug or biological constituent part must be submitted within fifteen calendar days. Products marketed under a device application have up to 30 calendar days.