The European Medicines Agency said that non-clinical and new approach methodologies could better predict the efficacy and safety of new medicinal products in humans compared with traditional methods such as animal testing.
A new European Specialized Expert Community (ESEC) has been established by the European Medicines Agency to support the regulatory acceptance of alternatives to traditional animal models in drug development and testing.
The group, known as the Non-Clinical and New Approach Methodologies (NAMs) ESEC, is expected to be fully up and running by the year-end and currently has more than 60
A US Supreme Court ruling in favor of the agency in an e-cigarette case has implications for drugs and other medical products as the justices decided not to disturb the FDA’s ‘change in position’ authority, while also creating a complex new landscape.
US FDA Commissioner Martin Makary’s call for placebo-controlled trials to confirm the efficacy of COVID-19 boosters is drawing a lot of criticism, but former Commissioner Robert Califf also supported the idea.
Autolus’s CAR T therapy obe-cel is among the medicines that are this week due for an opinion by the European Medicines Agency on whether they should be marketed in the EU.
