Most Expedited Reviews For Generic HIV Drugs Are For Single Agents – FDA
FDA is expanding its program to expedite the review of fixed-dose combination and co-packaged HIV drugs to include single-ingredient copies of certain antiretroviral drugs, according to a recently released final guidance
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FDA is setting a goal of reviewing fixed-dose combinations of HIV drugs in six weeks as part of the Bush Administration's $15 bil. Emergency Plan for AIDS Relief
Industry also seems supportive of the idea, while Pew touts the power of the power of track-and-trace as a deterrent.
EMD Serono has been tracking Serostim packages since 2002; J&J is using Prezista 600 mg as a trial run for serialization.