CDRH director Jeffrey Shuren says FDA believes there is more Philips Respironics needs to do as part of its recall of ventilators and BiPAP and CPAP m...
FDA publishes a draft guidance to assist sponsors in developing drugs and biologics to treat stimulant use disorders.
FDA grants Noxopharm an Orphan Drug Designation for CRO-67, a drug candidate for treating pancreatic cancer.
Medtronic warns healthcare professionals about stolen defective McGRATH MAC video laryngoscopes that have been offered for sale illegally by unauthori...
FDA researchers say they found no difference in safety when patients were switched between interchangeable biosimilars and the reference biologic.
FDA warns Atlantis, FL-based Dr. Luis Pena-Hernandez about objectionable conditions in his work conducting a clinical investigation.
Biomic Sciences recalls all lots of ION Sinus Support, ION Biome Sinus, and Restore Sinus Spray products due to microbial contamination concerns.
Attorney and data scientist Bradley Thompson blasts CDRH for its lengthy delays of up to 8,000 days in answering an average of 13 citizen petitions a ...
