FDA approves a Synapse Biomedical PMA for the NeuRx Diaphragm Pacing System for use in patients with spinal cord injuries who rely on mechanical venti...
Federal Register notice: FDA announces the availability of a draft guidance entitled Human User Safety (HUS) in New and Abbreviated New Animal Drug Ap...
FDA publishes the last in a series of four guidances on aspects of patient-focused drug development.
The Justice Department charges three former top officials at Magellan Diagnostics over their role in allegedly concealing a device malfunction that pr...
FDA warns Somerset, NJ-based Aspire Pharmaceuticals about multiple violations in its production of dietary supplements and human drugs.
Scorpion Capital says its research into deaths and adverse events associated with Harmony Biosciences narcolepsy drug Wakix indicates FDA should withd...
CDER issues an updated MAPP for Office of Clinical Pharmacology IND review processes.
FDA posts a draft guidance entitled Human User Safety in New and Abbreviated New Animal Drug Applications to inform sponsors of the types of informati...
