FDA, EMA Launch Pilot To Give Parallel Advice On Complex Generic Drugs

FDA and the European Medicines Agency on Wednesday (Sept. 15) launched a pilot program through which both agencies will provide parallel scientific advice to generic drug makers who are pursuing marketing approval for their products through FDA’s complex generic pathway or through EMA’s hybrid products path. The program is expected to help applicants understand the reason for FDA’s and EMA’s regulatory decisions, boost applicants’ global product development programs, and help applicants avoid unnecessary replication of studies or unnecessary testing methodologies...