Federal Register notice: FDA makes available a revised draft guidance entitled Promotional Labeling and Advertising Considerations for Prescription Bi...
Three SheppardMullin attorneys say that manufacturers of tests labeled for research use only should review customer lists and promotional claims to be...
Fresenius Medical Care recalls its Stay-Safe Catheter Extension Sets and Stay-Safe/Luer Lock Adapters to correct their instructions for use to prevent...
FDA publishes a draft guidance on using patient performance status as eligibility criteria for cancer drug trials.
FDA publishes a draft guidance with recommendations for increasing cancer drug trial participant diversity by selecting appropriate laboratory values ...
FDA warns Cardinal Health it is distributing unapproved medical devices that also have a Quality System Regulation violation.
InfuTronix recalls its Nimbus infusion pump systems due to multiple potential failure modes that may include battery failure, upstream blockage (occlu...
FDA clears an Expanse ICE 510(k) for the ICE Aspiration System for use in peripheral thrombectomy procedures.
