- cafead Sep 13, 2024 at 10:26: AM
via The FDA should be more open and collaborative to unleash a surge in approvals of rare disease drugs, according to a report by the National Academies of Sciences, Engineering, and Medicine.
Congress asked the FDA to contract with the National Academies to conduct the study. The brief focused on the flexibilities and mechanisms available to regulators, the use of “supplemental data” in the review process and an assessment of collaboration between the FDA and its European counterpart. That brief has spawned a 300-page report that provides a road map for kick-starting orphan drug innovation.
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Congress asked the FDA to contract with the National Academies to conduct the study. The brief focused on the flexibilities and mechanisms available to regulators, the use of “supplemental data” in the review process and an assessment of collaboration between the FDA and its European counterpart. That brief has spawned a 300-page report that provides a road map for kick-starting orphan drug innovation.
article source