For decades FDA regulations have required manufacturers who have knowledge about off-label uses of their products to include such information in their labeling. The agency is now proposing to eliminate the requirement, and attorneys are encouraging firms to take this opportunity to push for further changes to off-label rules.
FDA Off-Label Reg Changes For Drugs Could Be Driven By Tobacco Policy
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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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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A new pilot aims to take Brazil closer to ‘digital transformation.’
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Pharmaceutical companies are being encouraged to reach out to NICE in relation to its HTA Innovation Lab, which provides a sandbox environment in which the health technology assessment body can test new methods of evaluating “innovative and disruptive” therapies.