Microphysiological systems such as organ-on-chip models could not only improve the translational success of drug candidates into the clinic, but also impact the 3Rs in non-clinical safety testing, according to the European Medicines Agency.
The European Medicines Agency is looking to foster the uptake of organ-on-chip (OoC) models and other microphysiological systems (MPS) in drug development and regulatory submissions, according to its planned revision of its seven-year-old guideline on the replacement, reduction and refinement (3Rs) of animal studies.
MPS models could be more predictive of in vivo biology than the in vitro and in vivo models currently used,...
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A new research ethics review system for multi-site clinical trials in Canada is expected to help improve study start-up times, avoid unnecessary duplication and boost the country’s competitiveness on a global stage.
With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be implemented.
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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