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.
FDA clears a Turn Therapeutics 510(k) for the Protego Antimicrobial Wound Dressing.
FDA releases an FDA-483 with seven observations from an inspection at an Aurobindo finished drug manufacturing facility.
FDA releases the FDA-483 with three observations issued following an inspection at a Lupin API manufacturing facility.
Federal Register notice: FDA submits to OMB an information collection extension for electronic drug product reporting for drug compounding outsourcing...