Hatch-Waxman

FDA Withdraws 128 Suitability Petitions to Implement PREA. Will FDA Go Further in Its PREA “Clean-Up” Efforts?March 12th, 2007
In Late February 2007, FDA announced in the Federal Register the withdrawal of approval of 128 suitability petitions in accordance with the Pediatric Research Equity Act of 2003 (“PREA”). FDA’s notice states: [T]hese approval decisions are being withdrawn because ANDAs were never submitted and PREA requires …