FDA Off-Label Reg Changes For Drugs Could Be Driven By Tobacco Policy
This article was originally published in The Pink Sheet Daily
FDA is eliminating ‘intended use’ regulation requiring firms to label products for unintended use when they have knowledge of such use.
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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.
Pharma and device industries had complained that rule is overbroad, violates the First Amendment and would increase company exposure to liability.
In response to MIWG petition, agency delays by one year implementation of final rule on what activity is considered evidence of a manufacturer's intended use of a product.