Larger box “would accommodate all five steps on the single back panel,” says Emergent executive Manish Vyas. But FDA says proposed DFl for OTC Narcan nasal spray “has not yet been officially submitted or reviewed.”
Emergent BioSolutions, Inc. acted fast, like the opioid overdose treatment it’s proposed for OTC sales, preparing labeling with instructions on a single page after the US Food and Drug Administration indicated it doubted spreading the information over multiple panels would be effective.
“What we're now proposing is a larger box, which would accommodate all five steps on the single back panel,” said...
Sean Keveney is largely unknown in the FDA law space, but likely is familiar and connected to the White House given his work on Trump’s antisemitism taskforce.
The program would allow early interactions with FDA staff to speed construction and approval of pharmaceutical manufacturing facilities in the US, but will staff be available?
The ups – and some downs – of the US FDA’s prescription, biosimilar, and generic user fees for FY 2026 are tabulated by the Pink Sheet.
Concerns raised by two recent studies prompt UK researchers to argue for greater regulation with regards to direct-to-consumer test kits.
The ups – and some downs – of the US FDA’s prescription, biosimilar, and generic user fees for FY 2026 are tabulated by the Pink Sheet.
Concerns raised by two recent studies prompt UK researchers to argue for greater regulation with regards to direct-to-consumer test kits.
OMUFA reauthorization bill including amendment with sunscreen regulation provisions passed by Senate committee, which also approved other provisions not included in House OMUFA bill.
