Many US Food and Drug Administration officials apologized at the beginning of their talks during the Regulatory Affairs Professionals Society Convergence conference. Not for a controversial new guidance or proposed rule, but because they were not there in person.
Shutdown Threat Forced US FDA To Cancel Some Travel
Several FDA staffers presented at the RAPS Convergence conference via Zoom and pre-recorded video instead, illustrating that just the threat of a shutdown can scramble FDA plans.
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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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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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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.
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The General Services Administration’s updated list of “assets identified for accelerated disposition” does not include any buildings at the agency’s headquarters in White Oak, MD after its original list of “non-core” government properties for disposal had more than half the buildings on campus.
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Sponsors should consider the DTC ad's audio as the major statement about a prescription drug’s side effects and then choose strategically how to display the accompanying text. TV ads are now employing banners and larger text to satisfy the rule’s “dual modality” requirement.
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Given the Trump Administration’s intense focus on cutting costs and increasing efficiency, industry and the FDA should focus on what is and is not working in PDUFA VII when negotiating the next agreement, lobbyists said at the BIO CEO and Investor Conference.
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Biotech execs and lobbyists try to explain the Trump Administration's policy strategy and how to thrive in it.