Federal Register notice: FDA announces its Web site address where CDRH will post two lists of guidance documents that the Center intends to publish in...
Federal Register notice: FDA submits to OMB an information collection extension for 510(k) Third-Party Review Program.
Innoveix Pharmaceuticals recalls all sterile compounded drug products due to sterility assurance concerns.
Federal Register notice: FDA sends to OMB an information collection extension for a guidance on cvms electronic submission system.
FDA issues a highly redacted 38-page Form-483 following a recent inspection at drug manufacturer Cipla in Goa, India.
FDA approves Eli Lillys Reyvow (lasmiditan) tablets for the acute treatment of migraine with or without aura in adults.
FDA clears a Think Surgical 510(k) for the TSolution One Total Knee Application for use in total knee arthroplasty.
A new study in JAMA suggests there is limited feasibility for the idea of replicating clinical trials using real-world evidence.