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U.S. Department of Health and Human Services

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New Guidance for Industry: Codevelopment of Two or More Unmarketed Investigational Drugs for Use in Combination

The Food and Drug Administration (FDA) is providing an opportunity to comment on a new draft guidance for industry entitled "Codevelopment of Two or More Unmarketed Investigational Drugs for Use in Combination." This guidance is intended to assist sponsors in the codevelopment of two or more novel (not previously marketed) drugs to be used in combination to treat a disease or condition.

This guidance provides recommendations and advice on how to address certain scientific and regulatory issues that will arise during codevelopment.

The guidance is not intended to apply to development of fixed-dose combinations of already marketed drugs or to development of a single new investigational drug to be used in combination with an approved drug or drugs, nor to vaccines, gene or cellular therapies, blood products, or medical devices.

Recent scientific advances have increased our understanding of the pathophysiological processes that underlie many complex diseases, such as cancer, cardiovascular disease, and infectious diseases, including HIV. This increased understanding has provided further impetus for new therapeutic approaches that rely primarily or exclusively on combinations of drugs directed at multiple therapeutic targets to improve treatment response and minimize development of resistance.

In settings in which combination therapy provides significant therapeutic advantages, there is growing interest in the development of combinations of investigational drugs not previously developed for any purpose. Because the existing developmental and regulatory paradigm focuses primarily on assessment of the effectiveness and safety of a single new investigational drug acting alone, or in combination with an approved drug, FDA believes guidance is needed to assist sponsors in the codevelopment of two or more unmarketed drugs.

This guidance is intended to describe a highlevel, generally applicable approach to codevelopment of two or more unmarketed drugs. It describes the criteria for determining when codevelopment is an appropriate option, makes recommendations about nonclinical and clinical development strategies, and addresses certain regulatory process issues.

Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by February 14, 2011.

Electronic comments on the draft guidance may be submitted to http://www.regulations.gov. Address comments to Docket No. FDA–2010–D–0616.

Submit written comments to the Division of Dockets Management (HFA–305)
Food and Drug Administration, 5630 Fishers Lane, rm. 1061
Rockville, MD 20852.

Richard Klein
Office of Special Health Issues
Food and Drug Administration

Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration