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Off-Label Use Of Transmucosal Fentanyl Creates Ethical, Practical Dilemma For US FDA

 
• By Michael Cipriano

Advisory committee panelists divided on whether to modify REMS for TIRF products to reduce their wide-ranging off-label use.

Risk Dial

As the US FDA mulls recommendations from the Drug Safety and Risk Management Advisory Committee the Anesthetic and Analgesic Drug Products Advisory Committee about potential modifications for the risk evaluation and mitigation strategy (REMS) for transmucosal immediate-release fentanyl (TIRF) products, the agency will have a moral and ethical dilemma on its hands when considering off-label use of these medications.

Panelists were presented with a series of data at an Aug. 3 meeting showing that TIRF products are used in...

More from Drug Safety

More from Pink Sheet

UK’s Decentralized Manufacturing Rules Designed To Allow For ‘Future Developments’

 
• By Eliza Slawther

The UK drug regulator acknowledges that technology will “move on” and, as such, has designed its decentralized manufacturing regulation to be as “enduring” as possible. Experts from the MHRA explain what products are covered by the new framework and how it has been future-proofed.

Global Guideline Signals ‘Paradigm Shift’ For Pregnant And Breastfeeding Women, Says EMA

 
• By Anabel Costa-Ferreira

The European Medicines Agency expects the International Council for Harmonization’s new guideline will help address the critical lack of data on the use of medicinal products in pregnant and breastfeeding populations.

Profit-Sharing AI Model Proposed To Boost Korean Drug R&D

 
• By Jung Won Shin

A differentiated profit-sharing model to accelerate the use of AI in drug development using clinical and patient data is being proposed in South Korea, but the idea faces multiple practical challenges