Recently, the Food and Drug Administration proposed amending its regulations in connection with drug labels to revise and clarify procedures for an approved drug or biological product to change the product labeling to reflect certain types of newly acquired information in advance of FDA’s review of the change. The basic […] Drug LabelsThis entry was posted in Prescription Drug and tagged drug labels drugs FDA prescription drugs on September 27, 2014 by Legal Sleuth® (updated 3205 days ago)
Recently, the FDA issued a nuvaring label change. Apparently, a nuvaring label change was approved by the FDA Center for Drug Evaluation and Research (CDER) on October 2013. The nuvaring label change was related to Thromboembolic Disorders and Other Vascular Problems. In particular, the nuvaring label change stated the following: […] Nuvaring Label ChangeThis entry was posted in Medical Devices and tagged blood clots deep vein thrombosis FDA heart attacks label change nuvaring pulmonary embolisms strokes on March 11, 2014 by Legal Sleuth® (updated 3305 days ago)
FDA, Topamax, Cleft Lip & Birth Defect: Back in March 2011, the FDA review of topamax was a startling revelation to many of its users. The FDA review of topamax published in 2011 concerning the use of TOPAMAX® during pregnancy stated that if you take Topamax during pregnancy, your baby […] FDA, Topamax, Cleft Lip & Birth DefectThis entry was posted in Birth Defect Personal Injury Prescription Drug and tagged birth defect cleft lip cleft palate FDA topamax on February 18, 2014 by Legal Sleuth® (updated 3216 days ago)