Mifepristone and the Administrative Procedure Act: Perspective of a former FDA commissioner and NCI director

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This week, Federal Judge Kacsmaryk of Northern District of Texas concluded that the FDA erred in 2000 when it granted Accelerated Approval to mifepristone as an agent to facilitate a medical abortion.

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Norman E. "Ned" Sharpless, MD
Professor, cancer policy and innovation, UNC Lineberger Comprehensive Cancer Center; Former director, National Cancer Institute; Former acting commissioner, Food and Drug Administration
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FDA recently approved Alternative Standard #25 related to the Mammography Quality Standards Act. Alternative Standard #25 allows the interpreting physician to provide an assessment of “Incomplete: Need additional imaging evaluation” for the follow-up report issued within 30 calendar days of an initial report that received an assessment of “Incomplete: Need prior mammograms for comparison.”
Norman E. "Ned" Sharpless, MD
Professor, cancer policy and innovation, UNC Lineberger Comprehensive Cancer Center; Former director, National Cancer Institute; Former acting commissioner, Food and Drug Administration

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