YOUR GO-TO SOURCE FOR ANALYSIS OF ISSUES AFFECTING THE PHARMA & BIOTECH SECTORS
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.
As we reported on Health Law Scan, the Centers for Medicare and Medicaid Services (CMS) issued an Open Payments COVID-19 Announcement on March 25, citing its plans to exercise enforcement discretion regarding the late or incomplete submission of Program Year 2019 data in some cases.
Through FDA’s Policy for Certain REMS Requirements During COVID-19 Public Health Emergency, FDA provides temporary relief from laboratory testing and imaging requirements for certain drugs and biologics subject to REMS with those specific prerequisites.
In light of the growing coronavirus (COVID-19) public health challenge, the FDA issued guidance on March 18 on general considerations for conducting clinical trials of medical products during the COVID-19 pandemic.
The FDA issued guidance on March 20 for the manufacture of hand sanitizers by companies not previously registered to make OTC drugs.
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.
With the increasing numbers of coronavirus (COVID-19) cases and the declaration of a global pandemic by the World Health Organization, the pharmaceutical and biotech industries are assessing how this situation may impact business operations.
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 US District Court for the Southern District of New York issued a potentially significant opinion with respect to ClinicalTrials.gov results posting on February 24. If upheld, clinical study sponsors and investigators may need to post certain study results for 10 years’ worth of clinical trials (2007–2017), which the US Department of Health and Human Services (HHS) had previously excluded from the requirement.
The US Court of Appeals for the Federal Circuit’s February 10 decision in Acetris Health, LLC v. United States provides important guidance regarding the determination of a product’s country of origin, which is a gating issue for prescription drug products the US government is permitted to buy.