us fda announces improved drug approval results for 2003

Inpharma 1421 - 24 Jan 2004 ■ The US FDA has announced improvements in overall drugs and biologics approvals for 2003, including decreases in the time required to review and approve most applications. Highlighting the success was the approval of 21 New Molecular Entities, up from 17 in the calendar year 2002. Priority approvals also increased, and 466 new and generic drugs and biological products were approved by the agency’s evaluation and research centres. The FDA anticipates that several new initiatives announced in 2003 will help lead to even faster approvals of safe and affordable medical treatments in the coming years. These initiatives include new regulations and systems to improve access to low-cost generic drugs, procedures which are expected to save US consumers > $US3 billion per year. Food and Drug Administration. FDA Sees Rebound in Approval of Innovative Drugs in 2003. Media Release : 15 Jan 2004. Available from: URL: http:// www.fda.gov 809030348 1 Inpharma 24 Jan 2004 No. 1421 1173-8324/10/1421-0001/$14.95 Adis © 2010 Springer International Publishing AG. All rights reserved

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Page 1: US FDA announces improved drug approval results for 2003

Inpharma 1421 - 24 Jan 2004

■ The US FDA has announced improvements inoverall drugs and biologics approvals for 2003,including decreases in the time required to review andapprove most applications. Highlighting the successwas the approval of 21 New Molecular Entities, upfrom 17 in the calendar year 2002. Priority approvalsalso increased, and 466 new and generic drugs andbiological products were approved by the agency’sevaluation and research centres. The FDA anticipatesthat several new initiatives announced in 2003 willhelp lead to even faster approvals of safe andaffordable medical treatments in the coming years.These initiatives include new regulations and systemsto improve access to low-cost generic drugs,procedures which are expected to save US consumers> $US3 billion per year.Food and Drug Administration. FDA Sees Rebound in Approval of InnovativeDrugs in 2003. Media Release : 15 Jan 2004. Available from: URL: http://www.fda.gov 809030348

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