FDA
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FDA updates guide on comms about unapproved use of approved medical products
Final guidance clarifies FDA approach and addresses issues the industry raised regarding a draft version.
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SEC dings Becton Dickinson $175m for misrepresenting product risks
The company failed to properly inform investors about regulatory challenges it was experiencing with the FDA.
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SEC charges Kiromic BioPharma for failing to disclose FDA holds
Two former executives were fined, but the company itself will not receive a civil penalty due to its self-reporting.