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YOUR GO-TO SOURCE FOR ANALYSIS OF ISSUES AFFECTING THE PHARMA & BIOTECH SECTORS
Morgan Lewis FDA, litigation, and healthcare lawyers authored a LawFlash outlining key issues that companies marketing products and services for coronavirus (COVID-19) should be aware of, including healthcare, FDA, clinical laboratory, product liability, and digital and telehealth laws and regulations.
As summarized in a July 17 LawFlash, FDA has resumed inspections of regulated domestic facilities using a new risk assessment rating system that takes into account the reopening phase of the applicable state, and county level COVID-19 statistics.
Our FDA lawyers discuss provisions in the Coronavirus Aid, Relief, and Economic Security (CARES) Act that are of particular concern and interest for the pharmaceutical, medical device, animal drug, and food industries, as well the potential effects of the stimulus package, in this recent LawFlash.
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.
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.
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.