FDA, Industry Reach Agreement On Major Portions Of Generic User Fee Program
This article was originally published in The Pink Sheet Daily
Executive Summary
Pending agreement includes a one-time fee for ANDA applications in the backlog.
You may also be interested in...
GDUFA Facility Fees Should Be Waived Until First ANDA Approved, Petition Argues
Bangladesh-based Square Pharmaceuticals says the fees are burdensome for first-time filers, given long approval times, but the firm’s citizen petition strategy may further delay approval of its ANDA.
Generic User Fee Waivers Created In Draft House Bill, Breaking FDA-Industry Agreement
FDA says it likely will oppose the provision because it would create more administrative complexity and increase fees paid by individual firms, but many provider and professional associations think waivers could help prevent and alleviate drug shortages.
ANDA User Fee Negotiations Finished; Backlog To Be Mostly Cleared By Year Five
The finalized generic drug user fee agreement would clear most of the ANDA application backlog by the end of the first program cycle.