Get Full Government Meeting Transcripts, Videos, & Alerts Forever!
Get email alerts on the Onshoring Pilot topic
No spam. Unsubscribe anytime.
FDA details 'onshoring' prioritization pilot requiring U.S.-based supply chain steps
Summary
Larson described a new ANDA onshoring pilot: finished dosage form manufacturer(s), API suppliers, and pivotal BE testing (or a BE waiver) must be located in the U.S. for eligibility under the current pilot.
Bailey Larson introduced a new ANDA prioritization pilot intended to support U.S. generic drug manufacturing. She said, under the current pilot, all three criteria must be met to qualify: the finished-dosage-form manufacturer(s) are located in the U.S.; active pharmaceutical ingredient suppliers are in the U.S.; and either pivotal bioequivalence testing was conducted in the U.S. or the ANDA qualifies for a waiver of BE testing.
"The criteria include the finished dosage form manufacturer or manufacturers must be located in The US. The active pharmaceutical ingredient or API suppliers, must also be located in The US. And either the pivotal BE testing was conducted in The US or the ANDA qualifies for a waiver of BE testing," Larson said. She noted the pilot was announced the prior fall and that meeting all three conditions is required under the current pilot.
