COVID Laboratory Testing Investigations
The U.S. Food and Drug Administration's (FDA) March 21, 2024, warning letter to Agena Bioscience Inc. (Agena), a genetic diagnostic test developer, generated a lot of immediate commentary among regulatory lawyers and...more
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
It came as a surprise to nobody in health care circles when, on Friday, September 29, 2023, the Food and Drug Administration (FDA) publicly announced that its much-anticipated proposed rule on laboratory developed tests, or...more
The Food and Drug Administration (FDA) issued a guidance on development and emergency use authorization of diagnostic and serological tests for the monkeypox virus following the Secretary of the Department of Health and Human...more
This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant activity between June 21 and July 20, 2022. During this period, the Supreme Court of the United States overturned Roe v. Wade, which historically...more
On November 15, 2021, the U.S. Department of Health and Human Services (HHS) announced the withdrawal of the policy established during the previous administration that limited U.S. Food and Drug Administration’s (FDA) ability...more
Back in the early days of the COVID-19 pandemic, we published a post outlining the different kinds of diagnostic tests that were being marketed and the different roles of the two main federal regulators that oversee the...more
Entrepreneurs, scientists, and politicians all recognize the important role of testing for the Coronavirus Disease 2019 (COVID-19). Manufacturers and laboratories commenced the development of various types of tests almost as...more
On August 19, 2020, the Trump administration made a major announcement that marks the latest development in the ever-evolving saga of the Food and Drug Administration’s (FDA) oversight of laboratory-developed tests (LDTs)....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
On August 25, 2020, CMS announced two new changes pertaining to nursing homes during the COVID-19 public health emergency. First, CMS published an interim final rule with comment period (IFC), which requires nursing home...more
What happened? On August 19, 2020, the U.S. Department of Health and Human Services (“HHS”) issued a single paragraph statement rescinding U.S. Food and Drug Administration (“FDA”) guidance documents concerning premarket...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
The U.S. Department of Health and Human Services (HHS) announced on July 14, 2020 that it is distributing rapid point-of-care diagnostic test instruments and tests to all 15,400 nursing homes throughout the country to...more
On May 23, 2020, the PA Department of Health (DOH) revised its guidance for ambulatory surgical facilities (ASFs) to require ASFs that intend to provide COVID-19 testing to patients and staff to hold the appropriate CLIA...more
With the spread of COVID-19, healthcare providers—including those that are more easily accessible to patients, like primary care practices and urgent care clinics—are looking for fast and reliable tests to diagnose infection....more
Food/Dietary Supplements - FDA Issues Avocado and Hot Pepper Sampling Reports – The Food & Drug Administration (FDA) has made available two reports related to the sampling of avocados and hot peppers for the presence of...more
On January 22, 2018, the Drug Enforcement Administration (DEA) issued a final rule entitled, Implementation of the Provision of the Comprehensive Addiction and Recovery Act of 2016 Relating to the Dispensing of Narcotic Drugs...more
On January 2, 2018, the Substance Abuse and Mental Health Services Administration (SAMHSA) issued a final rule entitled, Confidentiality of Substance Use Disorder Patient Records. The final rule makes changes to the SAMHSA...more
On November 27, 2017, the Food and Drug Administration (FDA) issued a guidance entitled, Pediatric Information for X-ray imaging Device Premarket Notifications. The guidance outlines FDA’s rationale regarding information that...more
A complex—and occasionally, inconsistent—patchwork of federal and state regulatory requirements apply to entities that perform human subjects research in the United States. In recognition of one such inconsistency, the...more
Over the past year, significant regulatory changes began to take shape that will have lasting effects on the laboratory industry for years to come. After publishing draft guidance regarding the regulation of laboratory...more
Most health-care lawyers are accustomed to monitoring the high profile areas of regulatory enforcement in health care. However, many hospital lawyers, whether in-house or outside counsel, are unaware of the potential...more
Integrating Physical and Behavioral Health: Strategies for Overcoming Legal Barriers to Health Information Exchange - A growing number of Medicaid officials believe that coordinating care across the physical and...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