In its March 20 guidance, FDA addresses postmarket adverse event reporting for drugs, biologics, medical devices, combination products, and dietary supplements during a pandemic. Kathleen Sanzo, Jacqueline Berman, Michele Buenafe, and Dennis Gucciardo explain the guidance in this LawFlash.
The FDA announced on March 18 that it is suspending onsite routine domestic inspections in an effort to slow the spread of the coronavirus (COVID-19) and help flatten the pandemic curve. This announcement follows a March 10 guidance that routine foreign inspections were suspended. For-cause inspections will proceed if deemed “mission-critical.” Dennis Gucciardo, Michele Buenafe, and Jaqueline Berman address the tools that FDA will use to oversee the safety and quality of FDA-regulated products during this emergency in their recently authored LawFlash.
Read the full LawFlash.
The US Nuclear Regulatory Commission (NRC) and state agencies oversee the possession and use of radiopharmaceuticals and medical devices containing radioisotopes. In this regard, the NRC recently issued two information notices in response to medical events arising from the administration of radiopharmaceuticals.
The first, Information Notice 2019-11, alerts medical-use licensees to four strontium (Sr)-82/rubidium (Rb)-82 generator elution events that resulted in patients receiving concentrations of Sr-82 and Sr-85 in excess of regulatory requirements. The IN describes four separate events in which approximately 90 patients were administered Rb-82 chloride for cardiac imaging that contained Sr-82 and Sr-85 concentrations in excess of the regulatory limits identified in 10 CFR § 35.204.
Now is the time for pharmaceutical manufacturers to review their Open Payments/Sunshine Act internal compliance procedures, data collection forms and databases, and reporting and recordkeeping templates for payments and transfers of value made to healthcare providers. On August 14, 2019, the Centers for Medicare and Medicaid Services (CMS) published a Proposed Rule seeking to expand the Open Payments program, including the number and types of covered recipients and payment categories. As a result, drug manufacturers have at least two reasons to quickly conduct a comprehensive internal examination of their Open Payments program.