FDA’s ‘Access’ Challenge Highlighted At Naloxone Meeting
This article was originally published in The Pink Sheet Daily
Executive Summary
‘Behind-the-counter’ placement of opioid overdose treatment doesn’t resonate with agency, even as it wants to broaden availability.
You may also be interested in...
Naloxone Behind-the-Counter? Petition Could Help Push Action
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.
Trial Dropouts Illustrate Worries For J&J, Other Later Entrants To COVID Vaccine Space
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.
PDUFA VII Could Expand US Real-Time Review Beyond Oncology
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.
Existing Subscriber?
Sign in to continue reading.
Need a specific report? 1000+ reports available
Buy Reports
Need a specific report? 1000+ reports available
Buy Reports
New to Pink Sheet?
Start a free trial today!
Register for our free email digests:
Register for our free email digests: