FDA Commissioner Margaret A. Hamburg’s Statement on the Passing of Dr. Charles Edwards
The U.S. Food and Drug Administration today approved Xalkori (crizotinib) to treat certain patients with late-stage (locally advanced or metastatic), non-small cell lung cancers (NSCLC) who express the abnormal anaplastic lymphoma kinase (ALK) gene.
The U.S. Food and Drug Administration today approved Botox (onabotulinumtoxinA) injection to treat urinary incontinence in people with neurologic conditions such as spinal cord injury and multiple sclerosis who have overactivity of the bladder.
The U.S. Food and Drug Administration today released its “Strategic Plan for Regulatory Science,” calling for a sweeping modernization of the science used in developing and evaluating products critical to the nation’s health, economy, and security.
Ray A. Matulka, Ph.D., Director of Toxicology; Douglas L. Marshall, Ph.D., Chief Scientific Officer, Microbiology; Jules Skamarak, Business Unit Manager, Eurofins INSIDER Partner Series Companies developing and distributing food and nutritional products for US and...
The FDA today issued draft guidance to help researchers and manufacturers design better quality clinical studies in support of premarket approval (PMA) applications for medical devices.
