FDA warns Petnet Solutions about CGMP violations in its manufacturing of positron emission tomography drugs.
Federal Register notice: FDA announces a 12/3-4 Science Advisory Board to the National Center for Toxicological Research advisory committee meeting.
Federal Register notice: FDA classifies continuous glucose monitor data management systems into Class 1 (general controls).
AstraZeneca announces positive progression-free survival results from the Phase 3 POSEIDON trial in previously-untreated Stage IV non-small cell lung ...
Medtronic gets an FDA Breakthrough Device designation for its fully implantable left ventricular assist device for patients with advanced heart failur...
FDA issues a draft guidance and a final technical conformance guide on electronic submission of IND safety reports to the FDA Adverse Event Reporting ...
An FDA-led drug shortage task force releases a report highlighting key reasons for drug shortages and potential enduring solutions.
Federal Register notice: FDA makes available a draft guidance for industry entitled Type V DMFs for CDER-Led Combination Products Using Device Constit...