1. Pink Sheet

A Milestone For Accelerated Approval: HIV No Longer Qualifies

 
• By Michael McCaughan

FDA is ruling out the accelerated approval pathway for antiretroviral drugs to treat HIV. In a climate where sponsors are eager to expand use of the pathway, that may sound like bad news – it isn’t.

The era of accelerated approval for HIV therapies is over.

FDA makes that clear in a short section on page 23 of a new draft guidance on drug...

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