A controversial Trump-era policy that blocked the US FDA from regulating laboratory-developed tests was binned by the Health and Human Services secretary on 15 November. As a result, the FDA will once again require emergency use authorizations or other clearances for new COVID-19 tests.
The US Department of Health and Human Services (HHS) has withdrawn a controversial 2020 dictate that blocked the Food and Drug Administration from regulating laboratory-developed tests (LDTs), allowing the agency to impose new requirements on submissions for COVID-19 diagnostics.
The FDA’s revised policy for COVID-19 tests, issued on 15 November, says new diagnostics should get an OK from...
An upcoming US FDA advisory panel meeting will discuss adding a new indication to allow dermal fillers to be used in the upper chest, or décolletage. Plastic surgeons expect this could drive interest in the procedure, which is already performed off-label.
A system of pre-regulatory review consultations for innovative drugs and devices in South Korea has contributed to the accelerated development of such products.
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.
