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FDA makes that clear in a short section on page 23 of a new draft guidance
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US FDA critics have long decried the practice of using informal communications to convey regulatory expectations as podium policy. In the Makary era, the phrase may need to be updated because the agency now seems to be specializing in policy by podcast.
While treatments for scleroderma are in development, none are approved for the condition that is associated with high morbidity and mortality. The European Medicines Agency says guidance on how to design development programs for the disorder is needed.
The FDA will use electronic health records to “get eyes” on drugs immediately after approval, Commissioner Martin Makary told the DIA 2025 Global Annual Meeting. He also wants to reduce development time with better communication and new approval pathways.
The group had been laid off as part of the 1 April reduction-in-force, which led to missed guidance publication deadlines.
