DE Under 3: End Human Trafficking in Gov. Contracts Act & Vaccination Mandate Updates
#WorkforceWednesday: EEOC's LGBTQ+ Guidance Blocked, Employer COVID-19 Update, NYC Prepares for Pay Transparency Law - Employment Law This Week®
Podcast: Impact of COVID-19 on Pharmacist Scope of Practice: Before and After the PREP Act - Diagnosing Health Care
Employment Law Now VI-116-Top 10 Employment Issues To Consider For The Summer Kick-Off
Podcast: OSHA's Permanent COVID-19 Standard and Enforcement Blitz - Diagnosing Health Care
#WorkforceWednesday: CA COVID-19 Policies Get Updates, NYC Pay Transparency Law Postponed, DOL Targets Worker Retaliation - Employment Law This Week®
#WorkforceWednesday: NYC Pay Transparency Law, Florida Diversity Training, and Cal/OSHA’s COVID-19 ETS - Employment Law This Week®
DE Under 3: DEAMcon22, Remarks from OFCCP Director Yang & EEOC Commissioner Sonderling & Vaccine Mandate Updates
DE Under 3: Vaccine Mandate Updates, Contractor Unique Entity Identifiers, EEOC Nominations & A Reduced VEVRAA Hiring Benchmark
#WorkforceWednesday: EEOC COVID-19 Charges Surge, NYC’s Pay Transparency Law, SCOTUS Considers PAGA - Employment Law This Week®
Hot Spots in Employment Law 2022
Federal Vaccine Mandates: What’s Next for Employers?
DE Under 3: Disability Unemployment, Cornell ILR & USDOL Women's Bureau Webinar Series & More
HIPAA Tips With Williams Mullen - COVID Health Information and HIPAA – Do You Know the Rules?
Looking back at 2021 and ahead to 2022
DE Under 3: Vaccination Mandates Continuing & Federal Contractor Minimum Wage
Podcast: Owner's Outlook: Vaccine Mandate for Construction Workers at Health Care Facilities - Diagnosing Health Care
DE Under 3: OFCCP Contractor Portal & Request for Comments for Functional Affirmative Action Programs (FAAPs)
Employer Vaccine Mandates and Exemptions
DE Under 3: OFCCP AAP Verification Portal 'Rules of Behavior', Vaccination Injunction Updates, & Recent Job Scam Alerts
On August 22, Moderna announced that FDA approved its supplemental Biologics License Application (“sBLA”) for a new formula of their COVID-19 vaccine, SPIKEVAX®, for individuals 12 years old and above. Emergency Use...more
As Big Molecule Watch continues to push past the bounds of biosimilars and into biologics, we are proud to announce the publication of two additional trackers concerning vaccines: the Vaccine Patent Litigation tracker and the...more
As an update to our previous report, Biocon Biologics Ltd. (a subsidiary of Biocon Ltd.) announced the successful completion of the transition of the acquired biosimilars business in approximately 120 countries, a year ahead...more
Earlier this year, we discussed the Eastern District of Pennsylvania’s decision to enter a Lone Pine order – that is, a case management order that requires all plaintiffs to produce evidence establishing specific elements of...more
The outbreak of the COVID-19 pandemic in 2020 spurred rapid medical and technological innovation, leading to new medicines and devices designed in response to the virus. Under the traditional U.S. Food and Drug Administration...more
In Part I of this three-part series, we focused on three mRNA technology market players: BioNTech, Moderna and CureVac. In this second post, we will focus on Translate BIO, Arcturus Therapeutics, and eTheRNA and discuss...more
In Washington: On April 13, the Centers for Disease Control (CDC) and Prevention and Federal Drug Administration (FDA) paused the production of the Johnson & Johnson vaccine after six women participants in the U.S. developed...more
In an unexpected twist to a troubling situation that began over two years ago, U.S. Special Counsel Henry Kerner penned a letter to President Biden on March 31, 2021 questioning the Food and Drug Administration’s (FDA’s)...more
Our “Innovation Conversations” series continues with our guest Dr. Claire Fraser, President of the American Association for the Advancement of Science (AAAS) and Director of the Institute for Genome Sciences at the University...more
In Washington: In a statement on Monday, Food and Drug Administration (FDA) Commissioner Stephen Hahn and Peter Marks, director of the agency’s Center for Biologics Evaluation and Research, responded that it was...more
ACI’s FDA Boot Camp returns in a completely interactive virtual format to help life sciences attorneys and executives to master the fundamentals of FDA Regulation... Gain essential working knowledge of core FDA concepts,...more
In addition to the incredible work of agency scientists and reviewers to get the first COVID-19 vaccines authorized for emergency use in December (as we covered in Part 2 of our year-end post), the Food and Drug...more
On Dec. 11, the U.S. Food and Drug Administration (FDA) issued the first emergency use authorization (EUA) for a vaccine for the prevention of the coronavirus disease 2019 (COVID-19). An EUA differs from an approval in that...more
Report on Medicare Compliance 29, no. 39 (November 2, 2020) - CMS said Oct. 28 that Medicare will pay hospitals extra when they treat inpatients with drugs or biologicals approved by the Food and Drug Administration (FDA)...more
Earlier this month, the FDA’s Center for Biologics Evaluation and Research issued its highly anticipated guidance outlining the agency’s current thinking on granting emergency use authorization (EUA) to investigational...more
Innovative technologies are being deployed to address the Western world’s major killer: cancer. Traditionally, cancer treatment has included surgery, chemotherapy, and radiation, but recently, the development of targeted...more
September 17, 2020 Update: The Trump administration is currently considering accelerating the approval of an experimental Covid-19 vaccine being developed by Oxford University and AstraZeneca. In line with FDA’s June 2020...more
After exploring some of the ethical questions involved in allocating and distributing a potential COVID-19 vaccine and the basic tenets of bioethics, we continue by delving into the ethical issues relating to the vaccine...more
Companies should use caution when making efficacy claims in marketing and advertising of dietary supplements, foods, biological products and other products purported to treat or prevent COVID-19. ...more
After a decade or more of research suggesting that the HPV vaccine could be effective in protecting against certain types of head and neck cancer, the FDA has finally given approval for this application of Gardasil 9, the...more
In response to the United States’ rapidly evolving public health situation, the US Food and Drug Administration (FDA) recently released guidance on high-complexity in vitro diagnostic (IVD) tests for COVID-19. This article...more
Cour de cassation, Commercial Chamber, 16 May 2018, No. 16-21638 - The French Cour de cassation upholds the Paris Court of Appeal’s decision to reject an SPC application for a biological medicinal product which was based...more
I. REGULATIONS, NOTICES, & GUIDANCE - On April 4, 2016, the Centers for Medicare & Medicaid Services (CMS) issued the Final Calendar Year (CY) 2017 Medicare Advantage Capitation Rates and Medicare Advantage (MA) and...more
On Oct. 8, the House Republican caucus did not select a candidate for Speaker of the House and selection has been delayed. The current Speaker, John Boehner (R-OH), had announced that he would step down and retire from...more