The Food and Drug Administration ("FDA") expands informed consent exceptions with a final rule permitting institutional review board ("IRB") waiver or alteration of elements for certain FDA-regulated minimal-risk clinical...more
Under the proposed regulation, sponsors and sponsor-investigators whose planned study falls within an exemption will not be required to submit an Investigational New Drug application ("IND") or comply with IND reporting...more
The Situation: In light of the now widespread adoption of electronic health records ("EHR") technology, the U.S. Department of Health and Human Services Office of Inspector General ("OIG") and Centers for Medicare & Medicaid...more