FDA Issues New Draft Guidance on Combination Therapy Codevelopment

Combination therapy—the use of two or more dugs to treat a disease or condition—has become an increasingly important treatment option in fields such as oncology and infectious diseases. In December 2010, the Food and Drug Administration (FDA) issued a new draft guidance, Guidance for Industry: Codevelopment of Two or More Unmarketed Investigational Drugs for Use in Combination, to assist pharmaceutical companies in developing such combination therapies. The draft guidance advises combination therapy sponsors on how to address scientific and regulatory issues that will arise during codevelopment of two or more novel drug products. Interested parties have until February 14, 2011 to submit comments on the guidance.

Click the link below to read the full alert.