The U.S. Food and Drug Administration commends the Institute of Medicine (IOM) for its thorough discussion and recommendations outlined in its report, “Countering the Problem of Falsified and Substandard Drugs.” The report identifies causes and public health consequences of substandard and falsified drugs and recommends a range of strategies to address the problem and to promote global dialogue and action.

A federal judge has ordered a California company and its owner to stop manufacturing and distributing drugs and dietary supplements in domestic commerce until their manufacturing operations comply with the Federal Food, Drug, and Cosmetic Act (the Act).

The U.S. Food and Drug Administration today approved Pomalyst (pomalidomide) to treat patients with multiple myeloma whose disease progressed after being treated with other cancer drugs.

Alzheimer’s disease draft guidance

February is American Heart Month, and the U.S. Food and Drug Administration has a tool to help you achieve a heart-healthy lifestyle. It’s called the Nutrition Facts Label, and it can be found on all packaged foods and beverages.

generic Doxil, doxorubicin, Sun Pharmaceuticals

Green Hope LLC, which does business as Rosewood Products, and owner, Phi G. Ye, of Ann Arbor, Mich., have agreed to a consent decree of permanent injunction for violations of FDA food safety regulations. The consent decree was signed by Judge David M. Lawson of the U.S. District Court for the Eastern District of Michigan, Southern Division, on January 28, 2013.

The U.S. Food and Drug Administration today approved Ravicti (glycerol phenylbutyrate) for the chronic management of some urea cycle disorders (UCDs) in patients ages 2 years and older.

The U.S. Food and Drug Administration announced today that a federal judge has approved a consent decree of permanent injunction against Ben Venue Laboratories, Inc., and three of its corporate officers for failing to comply with current good manufacturing practice requirements as required by federal law.

The U.S. Food and Drug Administration today approved Kynamro (mipomersen sodium) injection as an addition to lipid-lowering medications and diet to treat patients with a rare type of high cholesterol called homozygous familial hypercholesterolemia (HoFH). The addition of Kynamro helps to reduce low-density lipoprotein-cholesterol (LDL-C), apolipoprotein B, total cholesterol, and non-high density lipoprotein-cholesterol (non HDL-C).