FDA’s advisory committee on testosterone-replacement products highlighted a regulatory conundrum the agency faces in terms of oversight of disease-awareness ads, and also illuminated potential promotional opportunities for marketers outside of the testosterone class.
Disease-Awareness Ads Thrive In Regulatory No-Man’s Land
FDA says its hands are tied when it comes to curbing practices such as the testosterone ads its advisory committees have found problematic, but are the agency’s powers really that limited?
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FDA Commissioner Martin Makary was sworn in Friday and knew of the plan that ultimately lead to CBER director Peter Marks' resignation on 28 March.
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In his resignation letter, the CBER director said he was willing to work with HHS Secretary Robert F. Kennedy Jr. to address concerns about vaccine safety, but "it has become clear that truth and transparency are not desired by the secretary."
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A former CMS manager worries casework and other necessary functions could suffer as a result of the 300 staff cuts at the agency that are part of a massive HHS restructuring.
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The April departures of Paul Kluetz and Marc Theoret follow resignations by other senior agency scientific staff and come on top of HHS’ plans to lay off 3,500 FDA employees.
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Pink Sheet reporter and editors discuss how staff may not be the only thing the FDA could lose with the latest layoffs announced by the Health and Human Services Department.
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Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.
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About 3,500 full-time FDA employees are expected to be laid off as part of a restructuring of the Health and Human Services Department and experts questioned whether the cuts could be implemented without harming FDA’s core mission.