Three industry stakeholders recommend that FDA add information to a draft guidance on pediatric studies of molecularly targeted oncology drugs.
FDA warns Indias Essnd Global about CGMP violations in its work as a contract manufacturer of finished drugs.
FDA warns Unetixs Vascular about Quality System violations in its manufacturing of vascular diagnostic ultrasound systems.
FDA warns KVK-Tech about CGMP violations in its production of finished drugs.
FDA announces three steps intended to make use of laparoscopic power morcellators in gynecologic surgeries.
FDA accepts for review a Genentech BLA for a fixed-dose combination of Perjeta (pertuzumab) and Herceptin (trastuzumab) with hyaluronidase, administer...
FDA approves a Perrigo Pharmaceutical ANDA for the first generic of Tevas ProAir HFA (albuterol sulfate) inhalation aerosol for treating or preventing...
FDA releases its latest batch of Warning Letters that includes Biomedix, JHS Svendgaard Hygiene Products, KVK-Tech, Unetixs Vascular and Yibin Lihao B...