Most Generic User Fee Rates Coming by Oct. 31, ANDA Filers to Pay About $50K

Generic-drug makers, including those with backlogged ANDAs and companies submitting prior approval supplements (PASs) and drug master files (DMFs), will know by the end of October how much user fee money they’ll have to dole out to the FDA in fiscal 2013. The FDA estimates that new ANDA filers will pay about $53,000, while companies submitting PASs will fork over about $27,000, according to a draft guidance slated for publication in the Aug. 27 Federal Register.
Drug Industry Daily