May 24, 20223 minCongress Must Hold FDA Commissioner Califf Accountable for ShortagesAmericans for Safe Drugs releases list of questions that Members of Congress should ask FDA Commissioner Robert M. Califf
Apr 14, 20223 minCPA Launches Americans for Safe DrugsFighting Against Chinese & Indian Generic Pharmaceutical Manufacturers Exporting Unsafe Products to the U.S.
Mar 10, 20221 minZydus hit with trio of FDA observations at Indian injectables plantIndia’s Zydus Lifesciences is in the FDA’s crosshairs once again, this time for a trio of unnamed violations at an injectables facility.
Mar 1, 20222 minAmerica’s Other Health Care Crisis: Generic Medicine Supply ChainsThe United States is dangerously dependent on foreign manufacturers—particularly in China and India—for essential, lifesaving generics.
Feb 9, 20221 minFDA Raises Concerns About China-Developed DrugsU.S. regulators are poised to tap the brakes on approving dozens of cancer drugs and other new medicines developed in China.
Feb 7, 20221 minGovernment Accountability Office: FDA Should Take Additional Steps to Improve Foreign InspectionsRecommends FDA develop tailored strategies and time frames to recruit and retain investigators for its foreign inspections.
Jan 16, 20221 minPopular Drug Used to Treat Type 2 Diabetes Recalled Over Cancer-Causing ImpurityThe FDA has announced the recall of one brand of a popular type 2 diabetes drug, metformin, over a potentially cancer-causing impurity.
Dec 14, 20212 minZydus recalls 4 lots of herpes injectable after complaints flag crystallization in vialsFears about potentially deadly crystallization in herpes drug vials have spurred Zydus Cadila to yank four lots from the U.S. market.