FDA publishes a draft guidance with information on how applicants and manufacturers should inform the agency about discontinuance of or interruptions ...
FDA warns Saint-Laurent, Canada-based Les Importations Herbasant about CGMP violations in its work as a contract drug manufacturer.
Three SheppardMullin attorneys say a recent Office of Prescription Drug Promotion untitled letter shows how FDA will continue to monitor DTC ads for a...
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.
