Commissioner Scott Gottlieb updates US FDA's initiative to prevent potentially fatal abuse of OTC loperamide, noting that online and conventional retailers are limiting product purchases while the agency continues evaluating the appropriate number of doses per package.
FDA is taking in retailers' input on limiting OTC loperamide purchases to curb abuse linked to preventing opioid withdrawal symptoms and in tandem is working with manufacturers to cut package sizes. An anticipated first step is elimination of 200-count packages, the largest size.
The effort is part of FDA's initiative to prevent potentially fatal abuse of the active ingredient in Johnson & Johnson...
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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