Commissioner Gottlieb says FDA is looking to work with provider groups to set dosage based on indication; Patrick Kennedy is calling on CMS to provide reimbursement for opioid addiction treatment.
US FDA Commissioner Scott Gottlieb said that "perhaps the biggest role" the agency can play in responding to the opioid crisis is by reducing overall exposure to opioids. FDA may be able to do so, he said, by encouraging more controlled dispensing so three to seven doses are dispensed rather than 30.
Gottlieb suggested that the agency could work with provider groups to build into opioid labeling what the appropriate dispensing should...
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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