Legally Qualified: Can Employers Require Vaccines?
Can Employers Require COVID-19 Vaccinations?
The FDA recently announced release of final transition guidance documents for medical diagnostic devices targeting COVID-19. The transition guidance documents are intended to guide COVID-19 diagnostic device manufactures as...more
On March 24, 2023, the Food and Drug Administration (FDA) finalized two transition plan guidance documents for medical devices that either 1) were issued Emergency Use Authorizations (EUAs), or 2) received enforcement...more
On September 27, 2022, the U.S. Food and Drug Administration (FDA) updated its COVID-19 Test Policy Guidance to encourage test developers to pursue full marketing authorization as opposed to Emergency Use Authorizations...more
For in vitro diagnostic test developers, the monkeypox public health emergency presents an urgent public health need for testing as well as a unique opportunity for rapid regulatory review of testing products....more
In vitro diagnostics (IVD) reform re-entered the legislative fray this week. The Verifying Accurate Leading-edge IVCT Development Act of 2021 (the “VALID Act of 2021,” the “VALID Act” or the “Act”) was introduced in both the...more
Our Health Care Group explains how emergency use authorizations (EUAs) have been issued during the current public health emergency and the benefits and limitations of offering a test pursuant to an EUA and provides practical...more
The pandemic year of 2020 presented FDA with many enormous challenges, including how to use emergency authorizations to approve diagnostic tests, personal protective equipment, and therapies, how to conduct remote...more
At the beginning of this week the FDA unveiled four new and updated guidance targeting vaccines, drugs and biologics, monoclonal antibodies and diagnostic tests. to address the impact of COVID-19 variants on the efficacy and...more
The U.S. Food and Drug Administration (FDA) has issued new guidance for COVID-19 test developers to evaluate the impact of emerging and future viral mutations on COVID-19 tests. The SARS-CoV-2 virus has mutated over time,...more
FDA announced that as of last week, 327 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 243 molecular tests and sample collection devices, 70 antibody...more
The Food and Drug Administration (FDA or the Agency) spent the remaining weeks of 2020 issuing Emergency Use Authorizations (EUAs) for the first over-the-counter (OTC) COVID-19 test to be performed at home and the first OTC...more
On December 15, 2020, the U.S. Food and Drug Administration (FDA) finally issued an emergency use authorization (EUA) for the first over-the-counter (OTC) fully at-home diagnostic test for COVID-19. The Ellume COVID-19 Home...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
Laboratory Developed Tests and Their Regulation - Laboratory developed tests (LDTs) are in vitro diagnostic tests (IVDs) that are designed, developed, manufactured, and performed within a single laboratory. Although the...more
On July 24, 2020, the U.S. Food and Drug Administration (FDA) reissued the LabCorp COVID-19 RT-PCR Test emergency use authorization (EUA) to include two new indications for use...more
Last week, on 23-25 June 2020, the U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) updated the responses to six of the Frequently Asked Questions related to laboratories and...more
On June 10, 2020, the FDA issued an emergency use authorization (EUA) for the first molecular diagnostic test that can generate information about the genomic sequence of the COVID-19 virus. The EUA was issued to Illumina,...more
There is substantial support for the view that reliable widespread testing is essential to the restoration of a semblance of normalcy in New Jersey when considering the impact of the COVID-19 pandemic. In connection with...more
The presence in the blood of antibodies specific to the novel coronavirus may help identify those who were unknowingly exposed to the virus but remained asymptomatic, those who were symptomatic but have fully recovered, and,...more
As an update to our prior blog post, on April 20, 2020 FDA announced the authorization of the first COVID-19 test for home collection of specimens. ...more
In mid-March, the US Food and Drug Administration announced via press release an “unprecedented policy” to increase testing capacity for COVID-19 in the United States. As part of its Policy for Diagnostic Tests for...more
To limit the spread of COVID-19 throughout the United States, the Food and Drug Administration (FDA) has promulgated policies to focus on the prevention, diagnosis, and treatment of the COVID-19 virus. Further, as states...more
U.S. authorities are actively policing entities making illegal promotional claims that products mitigate, prevent, treat, cure, or diagnose COVID-19....more
U.S. Senator Rand Paul introduced legislation that would place laboratory developed testing procedures within the Clinical Laboratory Improvement Amendments (CLIA) process and assess the availability and utilization of...more
FDA has just issued what it calls “FAQs on Diagnostic Testing for SARS-CoV-2” that provides information on which tests and which testing laboratories have received Emergency Use Authorization for the testing for the COVID-19...more