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.
Jacqueline Corrigan-Curay, the acting director of the Center for Drug Evaluation and Research wrote in an email to colleagues that she will be retiring from the agency in July.
