hiv/aids drug approval process to pick up speed

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Inpharma 1438 - 22 May 2004 Plans to speed up the approval of copycat versions of HIV and AIDS drugs have been announced by the US government as part of its $US15 billion AIDS relief programme. Products could win FDA approval in as little as two weeks under the terms of the draft guidance, and will be available to millions of people in developing countries at much reduced prices. Currently, the standard FDA drug approval process is 12 months, or 6 months for the fast-track process. The government’s new plans have also been designed to encourage the development of new combination drugs. Fees for products assessed under the new rapid review process could also be reduced or waived by the FDA as part of the plan. US steps up AIDS drug approval. Pharma Times News [online] : [2 pages], 18 May 2004 800973394 1 Inpharma 22 May 2004 No. 1438 1173-8324/10/1438-0001/$14.95 Adis © 2010 Springer International Publishing AG. All rights reserved

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Inpharma 1438 - 22 May 2004

■ Plans to speed up the approval of copycatversions of HIV and AIDS drugs have been announcedby the US government as part of its $US15 billionAIDS relief programme. Products could win FDAapproval in as little as two weeks under the terms ofthe draft guidance, and will be available to millions ofpeople in developing countries at much reducedprices. Currently, the standard FDA drug approvalprocess is 12 months, or 6 months for the fast-trackprocess. The government’s new plans have also beendesigned to encourage the development of newcombination drugs. Fees for products assessed underthe new rapid review process could also be reduced orwaived by the FDA as part of the plan.US steps up AIDS drug approval. Pharma Times News [online] : [2 pages], 18May 2004 800973394

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Inpharma 22 May 2004 No. 14381173-8324/10/1438-0001/$14.95 Adis © 2010 Springer International Publishing AG. All rights reserved