Manufacturers looking to stay out of regulatory hot water for conveying the off-label uses of their medical products to health care professionals (HCPs) should consult new final guidance from the Food and Drug Administration.
FDA Publishes Final Guidance For Communicating Off-Label Uses. First Amendment Questions Remain
The US FDA final guidance uses a Q&A format to help manufacturers navigate the regulatory landscape for communicating the off-label uses of their medical products to health care professionals. However, some say the final document fails to address potential free speech concerns.
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