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Biotech / Medical : Biotech Valuation -- Ignore unavailable to you. Want to Upgrade?

To: Biomaven who wrote (6818)	7/29/2002 10:02:08 AM
From: Biomaven	Read Replies (1) \| Respond to of 52153

This report doesn't reflect the slowdown I suspect we've seen in 2001/2002: Monday July 29, 9:14 am Eastern Time Press Release SOURCE: Tufts Center FDA Review and Approval Times for New Drugs Have Shortened, According to Tufts Center for the Study of Drug Development BOSTON--(BW HealthWire)--July 29, 2002--Time required by the U.S. Food and Drug Administration (FDA) to review and approve new drugs and biopharmaceuticals has shortened substantially under the Prescription Drug User Fee Act (PDFUA), a new analysis released today by the Tufts Center for the Study of Drug Development has found. According to the study, average approval times for priority-reviewed new chemical entities (NCEs) and new biopharmaceuticals decreased by 40% and 37%, respectively, between FY 94-97 and FY 98-00. Average approval time declined from 11.9 months to 7.1 months for NCEs submitted in FY 94-97 compared with those submitted in FY 98-00, and dropped from 12.6 to 8.0 months for biopharmaceuticals during the same period. "Our analysis suggests that PDUFA's principal goal of reducing lengthy regulatory review and approval times is being met," said Dr. Kenneth I. Kaitin, director of the Tufts Center. "High priority drugs -- those that offer the greatest therapeutic value to the patient -- have benefited the most." When first passed in 1992, PDUFA was meant to foster quicker and more predictable reviews of drug applications without costing taxpayers additional money. After Congress, the FDA, and drug developers judged the initial program successful, Congress renewed it in 1997, adding provisions to speed FDA responsiveness and communication with industry sponsors. Congress recently renewed the law again, which is scheduled to take effect on October 1. PDUFA created a system whereby drug developers pay fees to the FDA in return for the imposition of performance goals designed to improve the speed and efficiency of the drug and biopharmaceutical review process. While approval times for priority-reviewed new drugs declined, results for standard-reviewed NCEs and new biopharmaceuticals were mixed. The Tufts Center found that average approval times for standard-reviewed NCEs fell by 9%, while those for standard-reviewed new biopharmaceuticals rose by 33% between FY 94-97 and FY 98-00. More recently, in 1998-2000, average approval times for priority-reviewed NCEs and new biopharmaceuticals were 59% and 64% shorter, respectively, than those for standard-reviewed products. Priority-review NDAs are those considered by the FDA to offer high therapeutic value and earmarked for expedited review. Standard-review NDAs are viewed as offering little or no therapeutic advantages over existing therapies and receive lower review status by the FDA. In addition to speedier average review times, priority-reviewed NCEs during 1998-2000 were more likely to be approved on the first review cycle than were standard-reviewed NCEs. However, the share of priority-reviewed biopharmaceuticals approved on the first cycle declined substantially during the same time. About the Tufts Center for the Study of Drug Development Since its founding in 1976, the Tufts Center for the Study of Drug Development (http://csdd.tufts.edu), affiliated with Tufts University, has been the leading independent source, both in the U.S. and abroad, for information about the efficiency and productivity of the research-based drug industry and the impact of government initiatives on the drug development process. Based in Boston, Mass., the Tufts Center provides strategic information to help drug developers, regulators, and policy makers improve the quality and efficiency of pharmaceutical development, review, and utilization. The Tufts Center conducts a wide range of in-depth analyses on pharmaceutical issues, and through its Institute for Professional Development hosts symposia, workshops, and public forums on related topics throughout the year. Contact: Tufts Center for the Study of Drug Development Peg Hewitt, 617/636-2185 or Business Communication Strategies Peter Lowy, 781/326-9980 Peter