FDA warns Chinas Nantong Furuida Packaging Products about a CGMP violation in its manufacturing of over-the-counter drugs.
FDA tells Vanda Pharmaceuticals that its ongoing review of a Hetlioz (tasimelteon) supplemental NDA has identified deficiencies that preclude discussi...
The Duke-Margolis Institute for Health Policy makes three recommendations to the House Ways and Means Committee on policy solutions for drug shortages...
FDA declines to appear before the House Energy and Commerce Oversight and Investigations Subcommittee as it holds a critical hearing on the agencys fo...
Percussionaire recalls its High Frequency Transport Phasitron Breathing Circuit Kits due to a product defect that causes over-pressurization.
Valneva says it has sold an FDA tropical disease priority review voucher for $103 million that it will use to fund research and development efforts.
FDA approves a 50% pain reduction indication for Boston Scientifics WaveWriter Spinal Cord Stimulator in treating chronic low back and leg pain.
Federal Register notice: FDA makes available a final guidance entitled Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3...
