- Docket Number:
- Issued by:
Guidance Issuing OfficeOffice of the Commissioner,Office of Clinical Policy and Programs,Office of Combination ProductsCenter for Biologics Evaluation and ResearchCenter for Drug Evaluation and ResearchCenter for Devices and Radiological Health
The purpose of this guidance is to discuss ways in which combination product sponsors can obtain feedback from FDA on scientific and regulatory questions and to describe best practices for FDA and sponsors when interacting on these topics. These interactions can occur through application-based mechanisms, such as the pre-submission process used in the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) and the formal meetings used in the Center for Drug Evaluation and Research (CDER) and CBER, or through Combination Product Agreement Meetings (CPAMs), as appropriate.
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 (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 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.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2019-D-4739.