A federal court ordered Morton Grove Pharmaceuticals on Friday to stop “directly or indirectly manufacturing, processing, packing, labeling, holding, or distributing any drug” product citing GMP regulations. The company is restrained from the aforementioned activity until its GMP operations are in compliance with applicable laws and regulations and certified as such by an expert.


The Court of Appeals for the Second Circuit ruled Monday that Pfizer’s program to make its drug tafamidis more affordable violated the federal Anti-Kickback Statute (“AKS”), 42 U.S.C. § 1320a-7(b)(2)(B).

The drug is currently the only drug approved by the United States to treat transthyretin amyloid cardiomyopathy, a rare and progressive heart condition, and costs

FDA’s user fee programs for prescription and generic drugs, medical devices, and biosimilars must be reauthorized by September 30, 2022. On June 8, 2022, the House passed its version of the Food and Drug Amendments of 2022, and on June 14, 2022, the Senate HELP Committee marked up the similarly situated Food and Drug Administration