On the heels of unprompted EMA review of Covid drug, FDA schedules adcomm for potential EUA
The FDA is now following through on an emergency use filing for a repurposed cancer drug that European regulators initially took an interest in.
The US agency said Wednesday that it is convening an adcomm meeting of its Pulmonary-Allergy Drugs Advisory Committee, slated for Oct. 6. The company behind the adcomm is Veru, a Miami-based biotech that originally started out as a cancer company.
The federal agency said in a public notice that as part of the adcomm, one of the focuses of the experts during discussions will include “the treatment effect size in the context of the high placebo mortality rate, the limited size of the safety database, and identifying the proposed population.”
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