The US Food and Drug Administration’s revised draft guidance on scientific communications to health care providers about a medical product's unapproved uses did not dampen industry’s decade-long objections to its regulation of such speech.
Off-Label Communication: Industry Opposes Exclusion Of Phase II Data From US FDA’s Guidance
Revised draft guidance about scientific information on unapproved uses (SIUU) of medical products is “impermissibly paternalistic and overly restrictive of scientific speech,” MIWG says.
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