Republicans Ratchet Up Attacks On US FDA’s COVID Response
Pair of letters that target research focus and therapeutic review speed is a potential preview of the kind of oversight that the agency may be subject to if the GOP retakes control of the House this fall.
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More than 70 Republican representatives object to CMS draft national coverage determination for Alzheimer’s disease drugs. They ask if CMS will treat future drugs approved under the accelerated approval pathway differently and how it will coordinate with FDA.
Senators ask US FDA to change statements in COVID-19 monoclonal antibody fact sheets that factors like race or ethnicity may place a patient high-risk of serious illness, saying they promote racist decisions.
Pink Sheet Podcast: FDA User Fee Bill Mark-Up, Postmarket Quality Requirements, Fewer Adcom Meetings
Pink Sheet reporter and editors discuss the first mark-up of the House FDA user fee bill, the likelihood of more postmarketing quality requirements for drug manufacturers, and the significance of the shrinking number of FDA advisory committee meetings.