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.
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...
The budget authority total, which is significantly higher than the amount floated in an April OMB draft document, suggests there may have been successful lobbying to increase FDA funding.
In this first in a series of articles looking at the potential impact of the MFN drug pricing policy on European pharmaceutical markets, EUCOPE’s Alexander Natz tells the Pink Sheet why the US policy underscores the importance of confidential net pricing.
The International Council for Harmonisation has identified four new topics that can benefit from global regulatory alignment, with timelines for initiating work to be determined later.
