FDA awards a multi-year grant to C-Path to advance standards and methodologies designed to generate real-world evidence from real-world drug data in a...
FDA releases its latest batch of Warning Letters that include KVK-Tech and Shilpa Medicare Limited.
FDA grants Abiomed 510(k) clearance for an all-in-one, compact cardiopulmonary bypass system called the Abiomed Breethe OXY-1 System.
FDA warns Indias Shilpa Medicare Limited about CGMP and field alert reporting violations in its manufacturing of finished drugs.
FDA issues a guidance on how ANDA applicants should accurately refer to a reference-listed drug, reference standard, and the basis of submission.
FDA says it is delaying until 2/3/2022 enforcement of compliance with PMA requirements for AED accessories.
NIH ends enrollment in a clinical trial of a Lilly investigational monoclonal antibody intended to treat hospitalized Covid-19 patients.
The Washington, DC District Court rules that a recent FDA decision to remove a decades-old compliance policy affecting unapproved homeopathic drugs ca...