FDA and Off-Label Communication – Getting Closer to Truth
Drug & Device Law
NOVEMBER 9, 2023
341 (2001)), calls “off-label use,” so we go with the majority naming convention. That’s a significant step forward, since it aligns the FDA’s view of permissible science more closely to what doctors (and Medicare) actually rely on in clinical situations. Plaintiffs Legal Committee , 531 U.S. T]he studies or analyses. . .
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