OTC proton pump inhibitors should carry a warning that the products do not eliminate risks of esophageal cancer from persistent heartburn, says the Esophageal Cancer Action Network in a citizen petition to US FDA. FDA should “immediately” require the warning, which should be bold and prominent.
FDA is being asked to add yet another safety warning to OTC proton pump inhibitors. A citizen petition requests requiring a label warning on the risk of esophageal cancer from persistent heartburn, a risk not lessened by PPI use.
“The warnings on current products are not sufficient to alert patients to the risk of esophageal cancer associated with persistent...
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.
It is unclear in a revised staff manual guide whether Commissioner's National Priority Voucher program approval “recommendations” from the drug and biologic center directors will be advisory or decisional, experts told the Pink Sheet.
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.
