FDA Draft Guidance on Co-Development of Novel Combination Drugs

This post was written by Paul Sheives.

The FDA has released for public comment a draft guidance document entitled Co-development of Two or More Unmarketed Investigational Drugs for Use in Combination.” The draft guidance is intended to apply to the co-development of two or more investigational new drugs not previously approved, rather than the development of fixed-dose combinations of already marketed drugs or a single new investigational drug to be used in combination with an approved drug or drugs. The draft guidance describes the criteria for determining when co-development is an appropriate option, makes recommendations about nonclinical and clinical development strategies during the various phases of development, and addresses certain regulatory process issues (interaction with FDA and marketing applications, labeling issues, and pharmacovigilance plans). FDA is accepting written comments until February 14, 2011.

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