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Vaccinations Regulatory Requirements

Fenwick & West LLP

What We’re Watching Ahead of BIO 2025: Trends Shaping the Future of Biotech

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As we head into BIO 2025 in Boston, our teams are closely watching trends in biotech and how those affect financings, business development, IP protection, risk, and litigation strategy. Here are eight key trends we’re...more

Cozen O'Connor

HHS Advocates Mandated Placebo-Controlled Trials for New Vaccines: Implications for Clinical and Regulatory Practice

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The Department of Health and Human Services (“HHS”) recently proposed a policy that would require all new vaccines to undergo placebo-controlled clinical trials prior to FDA approval. The proposal, while controversial, is...more

Butler Snow LLP

Turnabout is Fair Play – “Junk Science” Litigation Aftermath: Requisite Retractions and Dubious Do-Overs

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Do plaintiffs’ experts get to put junk science before juries more often than their opinions are excluded? The answer is a resounding “probably.” Even in light of the December 2023 amendment to Federal Rule of Evidence and its...more

Alston & Bird

Health Care Week in Review | Senate Passes First Budget Resolution; DOJ Opts to Continue Defense in Braidwood SCOTUS Case

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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

Goodwin

UK’s MHRA Grants Marketing Authorization for Chikungunya Vaccine

Goodwin on

On February 5, 2025 Valneva SE (“Valneva”) announced that the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) granted marketing authorization for Valneva’s chikungunya vaccine, IXCHIQ. ...more

Cozen O'Connor

COVID Vaccine No Longer Required for Adjustment of Status Applicants

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On January 22, 2025, USCIS posted an alert pertaining to the I-693 immigration medical exam required for most individuals applying to become lawful permanent residents. USCIS indicates that they now “waive[s] any and all...more

Arnall Golden Gregory LLP

OIG Approves Pharmaceutical Manufacturer’s Proposed Free Vaccination Program

The Department of Health and Human Services, Office of Inspector General (“OIG”) recently released a favorable advisory opinion, OIG Advisory Opinion No. 24-11 (the “Opinion”), to a pharmaceutical manufacturer (the...more

Bradley Arant Boult Cummings LLP

Out with the Old? Not So Fast! A Quick Review of 2023 Highlights

2023 has brought many updates and changes to the legal landscape. Our blog posts have covered many of them, but you may not remember (or care to remember) them. Before moving on to 2024, let’s take a moment to review our top...more

Foley Hoag LLP

FDA Releases First New COVID-19 Vaccine BLA Guidance Since 2020

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Executive Summary - On October 19, 2023, the Food and Drug Administration (FDA) released a final guidance document titled Development and Licensure of Vaccines to Prevent COVID-19: Guidance for Industry, providing...more

Health Care Compliance Association (HCCA)

[Event] Regional Healthcare Compliance Conference - September 8th, Waltham, MA

Looking for compliance education and networking in your area? HCCA’s Regional Healthcare Compliance Conferences offer practitioners convenient, local compliance education that covers a wide variety of current and emerging...more

Sheppard Mullin Richter & Hampton LLP

Tracking the Waivers: Implications of the Wind Down of the COVID-19 Public Health Emergency

The White House recently announced that the COVID-19 national emergency and public health emergency (PHE) declarations will end on May 11, 2023. These declarations have been in place since the beginning of the COVID-19...more

Sheppard Mullin Richter & Hampton LLP

Further Updates to Cal/OSHA’s COVID-19 Emergency Temporary Standards Likely Coming Soon

At its upcoming April 21, 2022 meeting, the California Division of Occupational Safety and Health (“Cal/OSHA”) Standards Board will decide whether to readopt the fourth iteration of its COVID-19 Emergency Temporary Standards...more

Alston & Bird

Alston & Bird Health Care Week in Review - January 2022 #4

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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

Littler

Puerto Rico Government Issues Three New Executive Orders in Relation to COVID-19

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On January 28, 2022, Puerto Rico Governor Pedro Pierluisi issued three additional executive orders in connection to COVID-19. These executive orders span a wide range of sectors, from travelers to private-sector employers and...more

FordHarrison

NYC Announces Mandatory Vaccine Requirement for All Private Employers

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Earlier today, NYC Mayor Bill de Blasio announced a first-in-the-nation vaccine mandate covering all private-sector workers in NYC that will take effect on December 27, 2021. According to Mayor de Blasio, the mandate will...more

Burr & Forman

Labor & Employment E-Note - November 2021

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Resources - Safer Federal Workforce Task Force Updates Guidance for Federal Contractors - On November 10, 2021, the Safer Federal Workforce Task Force updated its Guidance for Federal Contractors (“Guidance”). As...more

Jenner & Block

Government Contractors Provided “Flexibility” Regarding Timing and Enforcement of COVID-19 Vaccine Mandate

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The last two weeks have brought a flurry of activity and changes to the Safer Federal Workforce Task Force (Task Force) Guidance issued pursuant to President Biden’s Executive Order 14042 (EO). ...more

Health Care Compliance Association (HCCA)

[Event] Richmond Regional Healthcare Compliance Conference - December 10th, Richmond, VA

Our one-day Regional Compliance Conferences provide attendees with a forum to interact with local compliance professionals, share information about your compliance successes and challenges, and create educational...more

BCLP

Update Regarding Mandatory COVID-19 Vaccination Policies

BCLP on

As many employers develop and implement mandatory COVID-19 vaccine policies, the legal landscape for federal and private vaccine mandates continues to develop. Below are a few recent developments in this area for all...more

Littler

Mandatory Employee Vaccines – Coming to A State Near You? (UPDATED)

Littler on

While available vaccines have proven highly effective in controlling COVID-19 and its variants to date, the virus continues to spread — particularly among unvaccinated populations. In the face of flagging interest, officials...more

Littler

Mandatory Employee Vaccines – Coming to A State Near You? (UPDATED)

Littler on

While available vaccines have proven highly effective in controlling COVID-19 and its variants to date, the virus continues to spread — particularly among unvaccinated populations. ...more

Quarles & Brady LLP

Guidance for Federal Contractors Under President Biden’s COVID-19 Executive Order

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President Biden recently issued an Executive Order (Executive Order 14042) requiring covered federal contractors to mandate that their employees are fully vaccinated against COVID‑19. On September 24, 2021, the White House’s...more

Society of Corporate Compliance and Ethics...

[Event] Dallas Regional Compliance & Ethics Conference - October 22nd, Frisco, TX

Our one-day Regional Compliance and Ethics Conferences provide attendees with a forum to interact with local compliance professionals, share information about your compliance successes and challenges, and create educational...more

Littler

Mandatory Employee Vaccines – Coming to A State Near You? (UPDATED)

Littler on

While available vaccines have proven highly effective in controlling COVID-19 and its variants to date, the virus continues to spread — particularly among unvaccinated populations. In the face of flagging interest, officials...more

Fenwick & West LLP

COVID-19 Developments for Federal Contractors and New York Employers

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HERO Act Plans Remain In “Active” Status for New York State Employers On September 6, 2021, New York’s Commissioner of Health designated COVID-19 as an airborne infectious disease under the Health and Essential Rights Act...more

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