Manufacturers face risk of whistle-blower suits and government enforcement actions when emergency use authorizations expire and pandemic recedes, attorneys say, but interaction with FDA and documentation may mitigate risk.
Manufacturers benefited from regulatory flexibilities that allowed them to get COVID-19 products on the market at lightening speed. But they could face government enforcement actions and litigation once the public health emergency ends and emergency use authorizations (EUAs) for their products are terminated.
“In a post-COVID pandemic world, that period of flexibility and the sense of collective urgency will eventually draw to a...
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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