US FDA Wants Assessment Of New Drug Review ‘Culture’ Amid Modernization, Other Changes
The New Drug Review Program is seeking a contractor to survey employees on the impact of team culture on performance and overall effectiveness.
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The request for an interview by the House Select Subcommittee on the Coronavirus Crisis seeks more information on the actions by President Trump and others to influence FDA decisions on HCQ, convalescent plasma, and vaccine decisions.
But CMS cautions that the announcement should not be read as a preview of its upcoming national Medicare coverage decision on Aduhelm and similar treatments.
US FDA’s New ‘Integrated’ Review Process Starts To Win Over Skeptics, But Industry Still Wants More Details
In an interview with the Pink Sheet, implementation director Rhonda Hearns-Stewart says FDA has modified the template for its 'integrated assessment' of marketing applications in response to feedback from reviewers and sponsors.