US Food and Drug Administration Commissioner Robert Califf met virtually on 12 January with the Endocrine Society to discuss the current research around puberty-delaying medicines, another signal that the FDA may soon need to weigh in on a contentious topic surrounding off-label use that is leading to uneven access to medical care for children and teenagers around the country.
On Puberty Blockers, FDA Is In ‘Listen Only’ Mode – For Now
Commissioner Califf’s agreement to a briefing from the Endocrine Society on the research related to puberty-delaying medicines for gender dysphoria in children and adolescents may signal the agency’s acknowledgement of the importance of the topic, which gets into broader issues surrounding FDA’s role in off-label use.
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