In its draft, "Prescription Drug User Fee Act (PDUFA) iv Drug Safety Five-Year Plan," the agency says it will focus on hiring the staff through fiscal year 2009.
The FDA has accepted the Company's NDA for filing and has set a Prescription Drug User Fee act (PDUFA) target action date for the Company's NDA of January 23, 2008.
Thirty-four of 35 were approved on or before the review time targets agreed to with industry under PDUFA, including three cancer drugs that FDA approved in less than six months.