Off-Label Use Final Rule: US FDA Declines To Focus Solely On Promotional Claims
In final rule describing the types of evidence the agency will consider in determining the ‘intended use’ of a product, FDA rejects industry requests to exclude ‘circumstances surrounding distribution’ and product design or composition.
You may also be interested in...
Battle Over US FDA’s ‘Intended Use’ Rule Continues
PhRMA and Pfizer attorneys criticize the rule’s broad evidence standard, lack of safe harbors, and disregard of the First Amendment. Opposition to the rule is expected to continue to play out in lawsuits.
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.
'Off-Label' Communications That Are Still 'Consistent' With Labeling Get Better Defined
US FDA's final guidance provides more examples of data that meets the 'scientifically appropriate and statistically sound' standard.