FDA, Industry Agree To Set Up Enhanced Pathway For Complex Generics

FDA reached a draft user fee pact with the generic drug industry that calls for a new approval pathway for drugs with complex active ingredients and formulations, as well as for drug-device combinations. The tentative agreement was unveiled by FDA Friday (Sept. 23), two days after an FDA official told House lawmakers that new policies being developed for complex and combination products could help bring generic versions of costly products like EpiPen to market. Generic drug industry stakeholders pegged the...