Drug regulators and research ethics committees in Germany have launched a pilot project to determine how they will meet the new rules and strict deadlines that the forthcoming EU Clinical Trials Regulation will introduce for processing clinical trial applications1.
Drug regulators and research ethics committees in Germany have launched a pilot project to determine how they will meet the new rules and strict deadlines that the forthcoming EU Clinical Trials Regulation will introduce for processing clinical trial applications1.
Drug companies are being invited to submit their clinical trial applications via the pilot. The regulators and ethics committees will...
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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.
