'Intended Use' Rule: US FDA May Toss Its 'Totality Of Evidence' Standard
Executive Summary
Pharma and device industries had complained that rule is overbroad, violates the First Amendment and would increase company exposure to liability.
You may also be interested in...
Off-Label Use: US FDA Backs Away From ‘Totality Of Evidence’ Standard In Proposed Reg
New proposed rule says a manufacturer’s knowledge of the unapproved use of a product does not alone determine intended use. Former FDA lawyer says rule could set off fireworks over the scope of what the agency considers evidence of off-label use.
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.
‘Intended Use’ Rule: Industry Urges US FDA To Revoke ‘Totality Of Evidence’ Standard
Trade groups say final rule would allow any activity to be considered evidence of a manufacturer’s intended use of a product and increase exposure to potential liability.