US FDA will list number of inquiries about acquiring samples for generic drug development, and also whether FDA sends letters to brand companies telling them it is safe to provide the generic sponsor with the samples.
The US FDA is preparing to launch its website to publish the names of drug companies suspected of using risk evaluation and mitigation strategies (REMS) to stonewall generic sponsor access to samples, in a move Commissioner Scott Gottlieb insists is not meant to publicly shame the brand firms.
The website, which could be launched as early as May 17, will specifically contain the amount of "inquiries" there are...
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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