Tag: label revisions
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July 2013 Update: New FDA Action To Be Taken In Or About September On Issue Of Drug Label Revisions By Generic Manufacturers
Allowing Supplemental Applications For Proposed Labeling Changes Might End Federal Preemption Shield From Legal Liability That Came With Mensing Ruling (Posted by Tom Lamb at DrugInjuryWatch.com) ______________________________________________________________________________ UPDATE: The FDA’s long-awaited proposed rule on…
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Pradaxa: 2012 Label Revisions In The U.S. And Canada, Where A “Dear Doctor” Letter Was Sent Out
New Case Report About Routine Fall Involving An Elderly Patient That Results In Fatal Irreversible Brain Hemorrhage (Posted by Tom Lamb at DrugInjuryWatch.com) Pradaxa® is the name under which Boehringer Ingelheim Pharmaceuticals, Inc. markets a prescription…