FDA Releases Guidance for Industry On Co-Development of Combination Drugs

The Food and Drug Administration announced in the June 14 Federal Register (78 Fed. Reg. 35,940) the availability of a guidance intended to assist sponsors codevelop two or more investigational drugs to be used in combination.

The guidance, Codevelopment of Two or More New Investigational Drugs for Use in Combination, provides recommendations and advice on how to address certain scientific and regulatory issues that may arise during co-development, the agency said.

Specifically, FDA said the guidance “describes the criteria for determining when codevelopment may be an appropriate option, makes recommendations about nonclinical and clinical development strategies, and addresses certain ...