For FDA, the sixth authorization of the Prescription Drug User Fee Agreement (PDUFA VI) marks a positive shift in the relationship between the agency and industry.
PDUFA VI: 'Building Trust' Is Theme Of FDA-Industry Negotiations
Major achievements of latest drug user fee agreement include focus on drug development cycle, more review time and pilot programs, FDA and industry reps tell DIA meeting.
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Mass FDA layoffs on 1 April were designed to spare product reviewers, but still touched many who are critical to the application review process or drug development, which could mean fewer treatments are brought to the US market first.
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FDA Commissioner Martin Makary was sworn in Friday and knew of the plan that ultimately lead to CBER director Peter Marks' resignation on 28 March.
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A former CMS manager worries casework and other necessary functions could suffer as a result of the 300 staff cuts at the agency that are part of a massive HHS restructuring.
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The April departures of Paul Kluetz and Marc Theoret follow resignations by other senior agency scientific staff and come on top of HHS’ plans to lay off 3,500 FDA employees.
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