Clinical Trials
HHS and its agencies violated the law by swiftly implementing “sweeping and poorly thought-through directives that ordered the bulk removal of healthcare resources,” including FDA draft guidances on diversity action plans and sex differences in clinical trials, a federal court said.
Industry associations EFPIA, EUCOPE and EURORDIS have praised the European Commission’s newly launched life sciences strategy, which will see investment funnelled into improving the clinical trial ecosystem and supporting advanced therapy development.
Sponsors should investigate signals of possible fraud in a manner that does not raise alarms or else evidence might disappear, UK and US regulators said.
Swiss health care products agency Swissmedic will launch a pilot in July to fast track clinical trial applications, which the agency claims will place Switzerland at the forefront compared to other European countries.