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GUIDANCE DOCUMENT

Requesting FDA Feedback on Combination Products Draft Guidance for Industry and FDA Staff December 2019

Draft

Not for implementation. Contains non-binding recommendations.

Docket Number:
FDA-2019-D-4739
Issued by:
Guidance Issuing Office
Office of the Commissioner, Office of Clinical Policy and Programs, Office of Combination Products
Center for Biologics Evaluation and Research
Center for Drug Evaluation and Research
Center 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 (generally the most efficient and effective approach), such as the pre-submission process used in CDRH and CBER  and the formal meetings used in CDER and CBER,  or through Combination Product Agreement Meetings (CPAMs),  as appropriate. 

We are publishing 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 prior to a CPAM, and the form and content of agreements reached through a CPAM.


Submit Comments

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:

Dockets Management
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.

Questions?

Contact Point
Combination Products Guidance Contact
Office of Combination Products
combination@fda.gov
301-796-8930
301-847-8619
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