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.
The FDA today issued draft guidance to help researchers and manufacturers design better quality clinical studies in support of premarket approval (PMA) applications for medical devices.
An agreement to establish a virtual Center of Excellence for Regulatory Science was signed today between the U.S. Food and Drug Administration’s National Center for Toxicological Research (NCTR) and the state of Arkansas.
