Release of several different safety announcements showcases US FDA Commissioner Gottlieb's efforts to quell potential public concerns with an active communication strategy.
A muscular public communications strategy has been one of the cornerstones of US FDA Commissioner Scott Gottlieb's tenure as head of the agency. And he is now using his now using his PR skills to home in on a topic of public interest as the federal government slogs through its third week of the shutdown: medical product safety.
While sponsors have begun to wonder whether the government shutdown will ultimately impact their drug review clocks, Gottlieb has done...
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.
The European Medicines Agency’s safety committee has concluded that the benefits of medicines containing metamizole continue to outweigh the risks but that new measures are needed to minimize the serious outcomes of agranulocytosis.
Finding the right way to measure outcomes is just one of the difficulties involved in conducting clinical trials of potential new therapies for loss of hearing, which can have a number of different causes.
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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