Legal Sleuth® ** Case Watch℠ - FDA Archives — Gooch Law Firm https://legalsleuth.com/tag/fda/ The Source for All Things Legal ℠ - Information, Resources and Services Tue, 28 Apr 2015 21:44:22 +0000 en-US hourly 1 https://legalsleuth.com/wp-content/uploads/2016/02/icon-34-150x150.png Legal Sleuth® ** Case Watch℠ - FDA Archives — Gooch Law Firm https://legalsleuth.com/tag/fda/ 32 32 Drug Labels https://legalsleuth.com/drug-labels/ Sat, 27 Sep 2014 18:07:23 +0000 http://legalsleuth.com/?p=5413 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 rule would allow holders of […]

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]]> Nuvaring Label Change https://legalsleuth.com/nuvaring-label-change/ Tue, 11 Mar 2014 17:59:58 +0000 http://legalsleuth.com/?p=5439 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: Stop NuvaRing use if an […]

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]]> FDA, Topamax, Cleft Lip & Birth Defect https://legalsleuth.com/fda-topamax-cleft-lip-birth-defect/ Tue, 18 Feb 2014 02:04:28 +0000 http://legalsleuth.com/?p=4802 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 has a higher risk for […]

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