The Burr Broadcast – Labor and Employment Update
Podcast: Impact of COVID-19 on Pharmacist Scope of Practice: Before and After the PREP Act - Diagnosing Health Care
#WorkforceWednesday: New COVID-19 Testing Guidance, NLRB Increases Use of Injunctive Relief, D.C. Amends Near-Universal Ban on Non-Competes - Employment Law This Week®
DE Under 3: Updated EEOC COVID-19 Technical Assistance Guidance, Case Decision & Wage & Hour Division Proposed Rule
COVID Laboratory Testing Investigations
#WorkforceWednesday: CA COVID-19 Policies Get Updates, NYC Pay Transparency Law Postponed, DOL Targets Worker Retaliation - Employment Law This Week®
HIPAA Tips With Williams Mullen - COVID Health Information and HIPAA – Do You Know the Rules?
Looking back at 2021 and ahead to 2022
Legally Qualified: What Employers Need to Know about COVID-19 Vaccination Requirements and Testing
#WorkforceWednesday: SCOTUS OSHA Decision Reactions and the Impact of New COVID-19 Benefits on Employers - Employment Law This Week®
#WorkforceWednesday: SCOTUS Decides on Vaccine Rules, Companies Can Still Require Vaccination, Restrictive Covenants in CO - Employment Law This Week®
Employment Law Now VI-110 - End of the OSHA ETS? Supreme Court Re-Issues A Stay
What will SCOTUS Decide on the OSHA ETS and CMS Vaccine and Testing Mandates?
#WorkforceWednesday: SCOTUS Considers Federal Vaccine Mandates, CDC Shortens Quarantine Periods, Definition of "Fully Vaccinated" - Employment Law This Week®
Discussion on Legal and Practical Issues
Update and Discussion on Practical and Legal Issues - NYS Paid Sick Leave, NYC Employment Law Update, New Whistleblower Law, COVID19
#WorkforceWednesday: Year in Review and a Look Ahead to 2022 - Employment Law This Week®
Employment Law Now V-109- BREAKING: OSHA ETS Stay is Lifted and Can Be Enforced Again
#WorkforceWednesday: Update on Federal COVID-19 Vaccine Rules and NY and NYC Vaccine Mandates - Employment Law This Week®
On October 7, 2024, FDA granted marketing authorization for the over‑the‑counter combination flu and COVID-19 combination test, Healgen Rapid Check COVID-19/Flu A&B Antigen Test. Although other at‑home combination tests...more
The U.S. Food & Drug Administration (FDA) issued two new versions of guidance documents for COVID-19 tests on January 12, 2023: Policy for Coronavirus Disease-2019 Tests (the “COVID-19 Test Guidance”) and Policy for...more
There were so many interesting and significant developments related to the various missions of the U.S. Food and Drug Administration (FDA) during the last week or so of September 2022 that we decided to create a summary...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
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
Updates on vaccines for young children and a massive study on the efficacy of mask-wearing in schools headline this week’s COVID-19 news....more
It is, somewhat amazingly, the beginning of January again. During this time of year we typically publish a series of blog posts that recap the most interesting Food and Drug Administration (FDA) activities over the prior 12...more
As of December 6, 2021, all air passengers 2 years or older (regardless of vaccination or antibody status) with a flight departing to the United States from a foreign country are required to show a negative COVID-19 viral...more
On November 15, 2021, the U.S. Food and Drug Administration (“FDA” or the “Agency”) issued the fifth edition of the Agency’s guidance entitled “Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency.”...more
As the COVID-19 pandemic progressed, the U.S. Food and Drug Administration (FDA) sought to provide timely guidance to the relevant stakeholders to support continuity and response efforts. Notwithstanding, on August 19, 2020,...more
On November 15, the U.S. Department of Health and Human Services (HHS) withdrew a controversial Trump-era HHS Policy Change that effectively prevented the Food and Drug Administration (FDA) from reviewing laboratory-developed...more
A new submission for a Food and Drug Administration (FDA) emergency use authorization (EUA), new guidance for travelers entering the U.S. and continued studies into the efficacy of booster shots headlined this week’s...more
Testing for COVID-19 certainly has evolved over the past 18 months or so. As supply and allocation continue to face challenges, guidance on serological/antibody versus viral testing, testing in the workplace, informed...more
Helpful Hints - HHS Releases Revised Reporting Requirements and Timeline for Provider Relief Fund Payments - On June 11, 2021, the U.S. Department of Health and Human Services released revised reporting requirements...more
We have seen biopharmaceutical companies around the world working to tackle COVID-19 in vaccine development, treatment development, and diagnostics, including the creation of world-class vaccines in record time, rapid tests...more
In the past week, Johnson & Johnson and Merck agreed to cooperate on production of the Janssen vaccine, and the Biden Administration used the Defense Production Act (DPA) to facilitate the arrangement. In addition, the GAO...more
In the past week, President Biden signed the Executive Order on America’s Supply Chains, kicking off a comprehensive review of supply chain risks. Meanwhile, the FDA issued an emergency use authorization (EUA) for the Janssen...more
Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in healthcare regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies, and...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
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
What a year for the Food and Drug Administration! FDA, an agency with regulatory oversight of 20-25% of products on which consumers spend, including food and medicines, but which typically stays out of the limelight, was...more
On November 30, Moderna announced that it is seeking FDA authorization for its COVID-19 vaccine. In addition, on November 17 the FDA issued an emergency use authorization for the first COVID-19 diagnostic test for...more
In Washington: On Sunday, White House Coronavirus Task Force coordinator Dr. Deborah Birx warned Americans to “assume that you’re infected” with COVID-19 if you traveled or gathered for Thanksgiving and advised being...more
In Washington: Wednesday, the House held its leadership elections reelecting Rep. Nancy Pelosi (D-CA) as Speaker of the House by her caucus. Other top Democratic leaders, Majority Leader Steny Hoyer (D-MD) and Majority...more