COVID Laboratory Testing Investigations
Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more
The House of Representatives and Senate recently passed an omnibus spending bill that funds the Federal government through Fiscal Year 2023 and contains various provisions affecting healthcare providers. Among other things,...more
October 10th was the last day for Governor Newsom to sign or veto laws that were passed by the legislature this year. 2021 was a busy year for California legislators, who put forth hundreds of health-related bills in the wake...more
The Centers for Medicare and Medicaid Services (“CMS”) published an Interim Final Rule in the Federal Register on September 2, 2020 to supplement and strengthen the agency’s enforcement of COVID-19 reporting requirements. The...more
Laboratory testing is a key factor in identifying or diagnosing COVID-19 patients, including during the asymptomatic phase, and determining appropriate treatment. With respect to COVID-19, laboratory testing is also critical...more
On May 4, 2020, the Food and Drug Administration (FDA) updated its “Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised) | Immediately in Effect Guidance for Clinical Laboratories, Commercial...more
Our Food, Drug & Device/FDA Team discusses why the Food & Drug Administration is engaging with personal protective equipment (PPE) manufacturers and how it’s providing information to health care providers to mitigate...more
Food/Dietary Supplements - FDA Investigates Multiple Foodborne Illness Outbreaks – The FDA and the CDC have launched a multistate investigation of a Salmonella Concord outbreak linked to certain tahini products. ...more
The U.S. Department of Health and Human Services (HHS) recently published a Final Rule granting patients and their personal representatives access to the patient’s completed laboratory test reports directly from the lab...more