340B covered entities may experience expanded access to contrast media, radiopharmaceuticals and other products at 340B prices in the coming months. Buried in the over 1,600 pages of the Consolidated Appropriations Act, 2023...more
The Therapeutic Products Directorate (TPD), the Biologic and Radiopharmaceutical Drugs Directorate (BRDD), and the Natural and Non-Prescription Health Products Directorate (NNHPD) have released their Drug Submission...more
The US Nuclear Regulatory Commission (NRC) recently issued its Report to Congress on Abnormal Occurrences for fiscal year 2020. The report documents key aspects of those events that the NRC considers “Abnormal Occurrences”...more
The US Nuclear Regulatory Commission’s (NRC’s) Advisory Committee on the Medical Uses of Isotopes (ACMUI) held a meeting on March 30 to discuss a variety of topics of interest, including recent trends in radiopharmaceuticals,...more
The NRC’s Office of Nuclear Reactor Regulation and Office of Nuclear Material Safety and Safety and Safeguards recently issued two Information Notices (INs) in response to medical events arising from the administration of...more
On April 20, 2015, the Federal Trade Commission (“FTC”) announced that Cardinal Health, Inc. (“Cardinal”), agreed to pay $26.8 million to resolve allegations that it violated Section 2 of the Sherman Act by monopolizing the...more
On April 17, 2015, the Federal Trade Commission (FTC) entered into a settlement with Cardinal Health, Inc. (Cardinal) to resolve allegations that Cardinal, the largest and in certain areas the sole operator of...more