Whether CME for pain management has the intended impact on prescribing is likely focus of new ‘suite of studies’ intended to assess the opioid REMS program. The challenges for FDA include teasing out the impact of the risk management program amid all the other public health efforts on opioids.
The US Food & Drug Administration is likely to revise the plans for assessing the opioid class-wide risk management program to ask for a number of different studies to test aspects of the continuing medical education program incorporated into the Risk Evaluation & Mitigation Strategy program.
Based on feedback during a 11 December workshop on the opioid REMS assessment process, FDA may need to “to...
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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