NCCS joined its patient advocate colleagues in the Cancer Leadership Council in comments on a Food and Drug Administration (FDA) document that provides guidance about the use of certain “expedited programs” that may be employed in the review of therapies for serious conditions. The FDA has updated the guidance regarding fast track and priority review authorities, amended its guidance regarding accelerated approval standards in accordance with the Food and Drug Administration Safety and Innovation Act, and offered its initial thinking about the procedures for drug sponsors to obtain breakthrough therapy status. NCCS and its colleagues commended FDA for developing a clear document that incorporates the guidance on all four programs and offered advice regarding standards for retaining breakthrough status once granted. The patient advocates also applauded the efforts of FDA to balance the need for clear evidence regarding safety and efficacy of new drugs and the need for efficiency and speed in the review process.
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