Communicating the scientific uncertainty that comes with US Food and Drug Administration-regulated medical products requires more nuance than just saying they are “safe.”
FDA Medical Product Communications Need More Nuance To Deter Misinformation, Experts Say
Government agencies and others need to improve their communication to a broad audience about the relative safety of vaccines, as well as current scientific uncertainty, experts said at the FDLI annual meeting.
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The agency’s compliance directors also discussed expectations for greater inspection and review efficiencies as part of the 1 October reorganization during a recent FDLI conference.
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The compounding industry ties for Martin Makary, President-elect Trump’s candidate to lead the FDA, could mean less compounding enforcement, experts said, but government officials said their enforcement focus will remain nonpartisan.
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The loss of institutional knowledge about OPDP’s prior comments on promotional materials can result in an enforcement letter for the new owner of a company or product, experts say.
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Written contracts should be detailed, require compliance with FTC and FDA requirements, and guard against activities that may damage a company’s reputation, experts said.
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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.