Topic: Combination Products

FDA Proposes New Policy to Boost Development of Fixed-Combination Drug Products

“FDA’s new interpretation of these terms would result in a determination of 5-year [New Chemical Entity] exclusivity for each active ingredient in a drug product instead of the drug product as a whole.”  (Carlson Caspers) The Food and Drug Administration has proposed a policy change that should give combination therapies a shot in the arm.… Read more »