A heads up for the biopharma and med-tech industries: The U.S. government is going beyond warning letters to slap companies for violating the FDA’s good manufacturing practice (GMP) regulations. KVK Research Inc., a U.S.-based generic drug manufacturer, pleaded guilty March 6 to two misdemeanor counts of violating the Federal Food, Drug and Cosmetics Act by introducing adulterated drugs into interstate commerce. As part of the plea, the company agreed to pay a proposed fine and forfeiture amount of $1.5 million.
The latest global regulatory news, changes and updates affecting biopharma, including: FDA clarifies terms for generics; FDA to hold public meeting on DSCSA; Russia updates COVID-19 guidelines; First Circuit: Prescriber’s perk indeed a kickback; Companies warned for documentation, FAR violations.