Combination Product Guidance Issued by FDA

FDA published guidance on Dec. 3, 2020 on how sponsors of combination products can obtain feedback from the agency regarding scientific and regulatory questions. The guidance also offers best practices for interacting with the agency, which can be in the form of application-based mechanisms and meetings with agency centers.

“We are issuing this guidance consistent with the Agency’s ongoing commitment to enhancing clarity and transparency regarding regulatory considerations for combination products, and in accordance with the mandate under section 503(g)(8)(C)(vi) of the FD&C Act [Federal Food, Drug, & Cosmetic Act] (21 USC 353(g)(8)(C)(vi)), which was added by section 3038 of the Cures Act. Section 503(g)(8)(C)(vi) requires FDA to issue a final guidance addressing: (1) the structured process for managing pre-submission interactions with sponsors developing combination products; (2) best practices to ensure FDA feedback in such pre-submission interactions represents the Agency’s best advice based on the information provided during these pre-submission interactions; and (3) how CPAMs [Combination Product Agreement Meetings] relate to other FDA meeting types, what information should be submitted with a request for a CPAM, and the form and content of agreements reached through a CPAM,” the agency stated in a press release.