FDA warns Cardinal Health it is distributing unapproved medical devices that also have a Quality System Regulation violation.
Three SheppardMullin attorneys say that manufacturers of tests labeled for research use only should review customer lists and promotional claims to be...
FDA publishes a draft guidance to help sponsors expand eligibility for cancer drug clinical trials in terms of washout periods and concomitant medicat...
InfuTronix recalls its Nimbus infusion pump systems due to multiple potential failure modes that may include battery failure, upstream blockage (occlu...
FDA publishes a draft guidance on using patient performance status as eligibility criteria for cancer drug trials.
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FDA publishes a draft guidance with recommendations for increasing cancer drug trial participant diversity by selecting appropriate laboratory values ...
Federal Register notice: FDA announces that OMB has approved an information collection entitled Electronic Records: Electronic Signatures.
