FDA’s ‘Access’ Challenge Highlighted At Naloxone Meeting
This article was originally published in The Pink Sheet Daily
‘Behind-the-counter’ placement of opioid overdose treatment doesn’t resonate with agency, even as it wants to broaden availability.
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The idea of “behind-the-counter” may be behind the times, but a request to put naloxone there could help push FDA’s existing interest in expanding access to the overdose antidote.
More than 5% of participants in J&J’s vaccine trial chose to be unblinded because they were eligible to receive a vaccine that had already gained a US FDA emergency use authorization.
A proposed pilot program would offer for “split submission and review” of some application sections in other disease areas. Discussions also touch on concept of a CDER-CBER RWE committee.