Apotex recalls one lot of fluticasone propionate nasal spray (50 mcg per spray) due to the potential for the product to contain small glass particles.
FDA approves an Aratana Therapeutics supplemental New Animal Drug Application for Nocita (bupivacaine liposome injectable suspension) to include its u...
Medtronic recalls its HeartWare Ventricular Assist Device (HVAD system) because of the possibility for an interruption to occur in the electrical conn...
FDA releases a guidance on Complicated Urinary Tract Infections (cUTIs): Developing Drugs for Treatment.
FDA makes available a draft guidance entitled Considerations for the Inclusion of Adolescent Patients in Adult Oncology Clinical Trials.
Federal Register notice: FDA makes available a draft guide entitled Recommended Content and Format of Complete Test Reports for Non-Clinical Bench Per...
Federal Register notice: FDA makes available a draft guidance entitled Assessment of Pressor Effects of Drugs.
FDA clears a Branchpoint Technologies 510(k) for its Aura ICP Monitoring System, an implantable and wireless intracranial pressure sensor.