FDA publishes a draft guidance to help sponsors expand eligibility for cancer drug clinical trials in terms of washout periods and concomitant medicat...
Federal Register notice: FDA announces that OMB has approved an information collection entitled Electronic Records: Electronic Signatures.
Federal Register notice: FDA makes available a revised draft guidance entitled Promotional Labeling and Advertising Considerations for Prescription Bi...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FDA publishes a draft guidance on using patient performance status as eligibility criteria for cancer drug trials.
FDA publishes a draft guidance with recommendations for increasing cancer drug trial participant diversity by selecting appropriate laboratory values ...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.
