FDA Might Seek "Intermediate" Action Authority To Enforce Trial Compliance
This article was originally published in The Gray Sheet
Executive SummaryFDA is considering whether to ask Congress for the authority to bring "intermediate" enforcement actions against parties violating clinical trial regs, FDA Office of Regulatory Affairs Director of Enforcement Daniel Michels told the Government Reform/Criminal Justice, Drug Policy and Human Resources Subcommittee.
You may also be interested in...
Discussions on the shape of health care have moved from “reimagining” to the next stage: building and executing on the vision. That is the thrust of EY’s NextWave Report: New Horizons 2019. Additionally, for medtechs seeking business continuum, “duality” is now a preoccupying thought.