Expanded Recall of Contaminated Injectable Cancer Drugs

In late April of 2015, the Food and Drug Administration (FDA) announced drug manufacturer Mylan N.V.’s recall of batches of contaminated Gemcitabine, an injectable drug used to treat ovarian, breast, pancreatic and certain types of lung cancer, after testing revealed that the batches contained foreign…

FDA’s Generic Drug Warning Labeling Rule Change

The New York Times recently published an editorial in support of the FDA’s generic drug labeling rule. AAJ (American Association for Justice) released an editorial board memo on generics and Katie Gommel (AAJ Press Secretary) did an outstanding job working behind the scenes with Public…

FDA to Review Rules for Over-the-Counter Drugs

The FDA has launched a review of the way it determines the safety of over-the-counter drugs such as acetaminophen. Current regulations allow the manufacturers of over-the-counter medications to drag their feet when it comes to updating warning labels. The process of increasing the warning on a…

Generic Drug Manufacturers Oppose FDA Label Proposal

The FDA has proposed label changes that would require generic drug manufacturers to update warning labels when new safety concerns come to light, even if those label changes have not first been made by the original manufacturer of the medication. The Generic Pharmaceutical Association, a…