us fda to blame for drug approval slow-down?

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Inpharma 1646 - 12 Jul 2008 The US FDA is responsible for the down-turn in new drug approvals, say research-based drug firms. Marketletter: Pharma News Daily reports that many analysts see the agency as having taken a stronger line on safety in the wake of the withdrawal of Merck and Co’s COX-2 inhibitor rofecoxib [Vioxx], resulting in a slow-down in new approvals. However, the director of the FDA’s Center for Drug Evaluation, Janet Woodcock, rejects the analysis, blaming a reduction in applications for the lowest number of marketing approvals (19 in 2007) since 1984. FDA slows down approvals, firms claim. Marketletter: Pharma News Daily : [1 page], 2 Jul 2008. Available from: URL: http:// www.news.marketletter.com 801035790 1 Inpharma 12 Jul 2008 No. 1646 1173-8324/10/1646-0001/$14.95 Adis © 2010 Springer International Publishing AG. All rights reserved

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Inpharma 1646 - 12 Jul 2008

■ The US FDA is responsible for the down-turn innew drug approvals, say research-based drug firms.Marketletter: Pharma News Daily reports that manyanalysts see the agency as having taken a stronger lineon safety in the wake of the withdrawal of Merck andCo’s COX-2 inhibitor rofecoxib [Vioxx], resulting in aslow-down in new approvals. However, the director ofthe FDA’s Center for Drug Evaluation, JanetWoodcock, rejects the analysis, blaming a reduction inapplications for the lowest number of marketingapprovals (19 in 2007) since 1984.FDA slows down approvals, firms claim. Marketletter: Pharma News Daily :[1 page], 2 Jul 2008. Available from: URL: http://www.news.marketletter.com 801035790

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Inpharma 12 Jul 2008 No. 16461173-8324/10/1646-0001/$14.95 Adis © 2010 Springer International Publishing AG. All rights reserved