To improve evidence generation in studies designed to bring therapeutic agents to market, FDA is urging drug sponsors not to skip dose optimization at the outset of clinical development. The agency is also telling industry that it’s open to accepting trials that have pragmatic elements and are augmented by data generated in academia.
The California Institute for Regenerative Medicine, a state agency tasked with awarding billions of dollars of scientific funding for stem cell and gene therapy, has rescinded a controversial policy that was disrupting the flow of funding to cancer research.
