When is a drug intended for a specific use? Not just when it's promoted as such, FDA says in long-awaited final rule
After more than 5 years of tweaks and delays, the FDA on Friday unveiled its final “intended use” rule, which clarifies the types of evidence relevant to determining whether a drug or device is intended for a new use, particularly one that might be off-label.
Over the years, biopharma industry groups have taken issue with the agency’s proposed changes on its intended use regulations, expressing concerns that the FDA could accuse companies of violating the law simply because the firm knew that a drug or device was being prescribed or used by healthcare providers off-label.
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