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FDA makes that clear in a short section on page 23 of a new draft guidance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FDA makes that clear in a short section on page 23 of a new draft guidance