Clinical Trials
A working group of EU regulators has developed a comprehensive repository of fee requirements relating to the Clinical Trials Regulation to help sponsors navigate the diverse demands of member states in the European Economic Area.
The MHRA’s new scientific dialog program will offer drug developers “closed-door meetings” that will offer “confidential, commercially sensitive discussion” with its staff to help them “refine” their real-world evidence generation strategies.
The UK’s “world-first” tailored regulatory framework for point of care manufacturing is set to enter into force this summer.
In new draft guidance, the US FDA recommends sponsors carefully weigh the circumstances for requiring tissue biopsies for clinical trial subjects and emphasizes the need to limit them in pediatric studies.