On July 22, 2019, FDA issued final guidance on postmarketing safety reporting (“PMSR”) for combination products. The guidance focuses on ways to comply with the PMSR rule for combination products that have received FDA marketing authorization.
After providing a background on combination products and how they are regulated, the guidance identifies general considerations for PMSR compliance. The guidance explains that the rule applies to two types of applicants: Combination Product Applicants and Constituent Part Applicants. Combination Product Applicants hold the only application(s) for a combination product. Examples of Combination Product Applicants are companies that hold an approved PMA for a drug-eluting stent, an approved NDA for a pre-metered dry powder inhaler co-packaged with a filled drug product cartridge, an approved BLA for a vaccine supplied in a pre-filled syringe, or both an approved PMA for a laser system for photoactivating a drug and an approved NDA for that drug.
Constituent Part Applicants hold an application for a constituent part of a combination product, where the applications for other parts are held by different applicants. Examples of Constituent Part Applicants include a company that holds an approved PMA for a laser system for activating a drug, where the approved NDA for the drug is held by a different company. Application type-based reporting requirements apply to both types of applicant, while constituent part-based reporting requirements apply only to Combination Product Applicants and information sharing requirements apply only to Constituent Part Applicants.
The guidance also discusses specific PMSR requirements in greater detail and identifies process considerations for Combination Product Applicants. It concludes with hypothetical examples to illustrate PMSR considerations for Combination Product Applicants and a chart of PMSR requirements by application and product type.