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Puberty Blockers: FDA's Califf Asked If REMS, Boxed Warning Against Off-Label Use In The Works

 
• By Sue Sutter

FDA Commissioner Robert Califf tells House appropriations subcommittee chair the agency will 'consider any information that may be available' on off-label use of puberty blockers for gender dysphoria before making a regulatory decision.

Gender dysphoria
The FDA is being pressed on treatments used off-label for gender dysphoria. • Source: Shutterstock

Congress is dragging the US Food and Drug Administration further into the debate of off-label use of drugs to treat children with gender dysphoria.

During an 18 April hearing on the agency's fiscal year 2025 budget request, Rep. Andy Harris, R-MD, a physician and chairman of the House Appropriations Subcommittee on Agriculture, Rural Development...

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More from Drug Safety

More from Pink Sheet

US Most Favored Nations Policy: Higher Drug Spending In Germany Is ‘Difficult To Imagine’

 
• By Francesca Bruce

Germany’s federal health care decision-making body, the G-BA, tells the Pink Sheet that German drug prices are fair and speculation of price rises in the market due to the US MFN policy is fear mongering.

EMA Rejects Treatments For Pediatric Myopia & CTCL

 
• By Vibha Sharma

EU marketing applications for drugs aimed at slowing myopia progression in children and for treating cutaneous T-cell lymphoma have been turned down by the European Medicines Agency.

Europe’s UPC Issues Landmark Ruling On Second Medical Use Claims

 
• By Neena Brizmohun

The verdict by the Unified Patent Court in the dispute between Sanofi/Regeneron Pharmaceuticals and Amgen explains what companies should look out for when deciding whether infringement has taken place when it comes to second medical use patents.