FDA Issues New Guidelines for the Co-development of Drugs

February 2, 2011

The FDA has just officially released rough guidelines for use by industry for the development of two or more novel investigational drugs, for use in combination.

The FDA has just officially released rough guidelines for use by industry for the development of two or more novel investigational drugs, for use in combination.

As stated by the FDA, “The guidance provides recommendations and advice on how to address certain scientific and regulatory issues that will arise during codevelopment. It 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.”

The FDA specifies that these guidelines are not meant to be enforced, but are merely recommendations for industry as they seek to co-develop drugs. The guidelines provide guidelines for the following aspects of development:

• Determining whether co-development is appropriate
• Preclinical development, including assessing the biological rationale and initially determining safety
• Clinical development, including phase I – III stages of clinical testing
• Regulatory processes

You can see the full set of recommendations here: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM236669.pdf