Codevelopment of Two or More New Investigational Drugs for Use in Combination June 2013

GUIDANCE DOCUMENT

• Docket Number: FDA-2010-D-0616
• Issued by: Center for Drug Evaluation and Research

This guidance is intended to assist sponsors in the codevelopment2 of two or more new drugs that have not been previously developed for any indication to be used in combination to trea disease or condition. For purposes of this guidance, these not-previously-developed drugs are referred to as new investigational drugs. The guidance provides recommendations and advice on how to address certain scientific and regulatory issues that may arise during codevelopment of two or more new investigational drugs. It is not intended to apply to development of fixed combinations of previously approved drugs or to development of a single new investigational drug to be used in combination with a previously approved drug or drugs. FDA believes the recommendations in this guidance relevant to demonstrating the contribution of the individual new investigational drugs to the effect(s) of the combination are consistent with the requirements of 21 CFR § 300.50, “fixed-combination prescription drugs for humans.” This guidance applies only to drugs and biological products regulated by the Center for Drug Evaluation and Research. The guidance is not intended to apply to biological products regulated by the Center for Biologics Evaluation and Research or medical devices.

---

Submit Comments

Submit Comments Online

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-2010-D-0616.