Swayed By Industry Opposition To 'Intended Use' Rule, FDA Definitively Delays Implementation
US FDA is considering calls to drop 'totality of circumstances' test and to clarify that mere knowledge of unapproved use does not constitute evidence the use was intended.
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'Intended Use' Rule: US FDA May Toss Its 'Totality Of Evidence' Standard
Pharma and device industries had complained that rule is overbroad, violates the First Amendment and would increase company exposure to liability.