5 Regulatory Trends Shaping Today’s Drug Development
Liz Narciso
Recent regulatory developments are reshaping how sponsors think about evidence, oversight, and operational readiness. In a New England Journal of Medicine Sounding Board, FDA leadership announced that one adequate and well-controlled clinical trial — supported by confirmatory evidence — could become the agency’s new default standard for approval.i The shift formally moves away from the long-standing expectation of... The post 5 Regulatory Trends Shaping Today’s Drug Development appeared first on