Consumer Healthcare Products Association looks to stem expansion of state-mandated drug take-back programs with programs that use existing facilities and infrastucture and don't require industry funidng, says state affairs VP Carlos Gutierrez. State bills limiting sales of DXM to minors and expansion of the NPLEx system to track PSE sales also are on CHPA’s radar.
Two states' establishment of mandatory OTC and Rx drug take-back programs with the pharma industry footing the bill has focused the Consumer Healthcare Products Association’s attention on asking state lawmakers for less drastic changes.
Carlos Gutierrez, the OTC industry trade group's vice president for state and local government affairs, says expansion of age restrictions...
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.
