Experts say two new guidances — issued without the usual public comment period — leave questions about how patients will navigate a growing pool of wearables.
FDA’s recent draft guidance, Regulatory Considerations for Prescription Drug Use Related Software, proposes a regulatory framework for software disseminated by a drug sponsor that supplements or ...
The Food and Drug Administration is scrutinizing the common practice of giving coronavirus and flu shots together, signaling a reversal of years of federal guidance and a broader crackdown on ...
A plan to slash Food and Drug Administration drug review times is raising alarms at the public health agency that's been ...
On Oct. 23, the FDA issued draft guidance titled “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses [SIUU] of Approved/Cleared Medical Products: ...
The free version of ChatGPT may provide inaccurate or incomplete responses — or no answer at all — to questions related to medications, which could potentially endanger patients who use OpenAI's viral ...
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