After years of industry prodding, FDA schedules a two-day public meeting in November to establish direction for off-label regulation, but the agency is already being pulled in multiple directions.
Stakeholders applauded FDA's announcement that it would hold a two-day public hearing to gather input on off-label medical product issues, but they are already pulling the agency in several different directions in terms of a desired policy approach.
FDA is finally jumping into the minefield of off-label prescribing with its Nov. 9-10 meeting, following years of push from...
The UK regulator approved 16 medicines containing a new active substance in the first half of this year, while the European Commission issued marketing authorizations for 20 NAS-containing drugs.
Joint clinical assessment reports must be descriptive rather than reach definitive conclusions, and must not interfere with national decision making processes, according to new EU guidance.
An effort to change the US Food and Drug Administration’s conclusion that its obesity treatment candidate retatrutide is a drug and not a biologic could give the product more time with unrestricted pricing in Medicare, among other benefits.
Glenmark Pharmaceuticals agreed to pay $25m in the US to resolve its alleged liability under the False Claims Act linked to price-fixing allegations.
Revised recommendation is based on most recent data on circulating strains in US, where KP.3 is now dominant. Novavax sticks with plans targeting the JN.1 ‘parent strain.’
Pink Sheet reporter and editors discuss the US FDA’s changes to the COVID-19 vaccine indication and its revocation of the vaccine emergency use authorizations, as well as new vaccine coverage and reimbursement questions.
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