The American Society of Anesthesiologists and attorney Scott Lassman disagree with the FDA's suggestion that studies showing all naloxone products can be used safely over the counter indicates all of them can be moved to nonprescription status. Both were included in comments submitted ahead of the agency's Nonprescription Drug and Anesthetic and Analgesic Drug Products advisory committee meeting on the subject.
Making all naloxone products available OTC in the US could limit, rather than expand, access to the opioid overdose treatment, according to comments submitted before US Food and Drug Administration advisors discuss the first naloxone switch proposal.
The American Society of Anesthesiologists and attorney Scott Lassman both made clear in comments, submitted to the docket for a...
The group had been laid off as part of the 1 April reduction-in-force, which led to missed guidance publication deadlines.
The developers of the ChAdOx1 NipahB vaccine will be able to benefit from the early and enhanced support that the European Medicines Agency offers through its priority medicines scheme.
The termination of the HHS Secretary’s Committee on Human Research Protections closed an important forum for discussing pediatrics and pregnancy in clinical trial design, a former SACHRP chair said.
