The US Supreme Court rules that, under the Federal False Claims Act (FCA), the knowledge and subjective beliefs of a defendant at the time a false claim was submitted are determinative, and post hoc objectively reasonable rationalizations of that behavior based on an interpretation of an ambiguous law do not excuse the violation; the FDA issues updated draft guidance for good clinical practices (GCP), incorporating the International Council for Harmonisation’s (ICH) recently updated E6(R3) draft guideline; the FDA issues a warning See more +

The US Supreme Court rules that, under the Federal False Claims Act (FCA), the knowledge and subjective beliefs of a defendant at the time a false claim was submitted are determinative, and post hoc objectively reasonable rationalizations of that behavior based on an interpretation of an ambiguous law do not excuse the violation; the FDA issues updated draft guidance for good clinical practices (GCP), incorporating the International Council for Harmonisation’s (ICH) recently updated E6(R3) draft guideline; the FDA issues a warning letter with implications for devices that shut off at the end of a subscription or report a limited number of events; the FDA requests public comments on the development of medical technologies for use in non-clinical care settings to advance health equity. See less -