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Infectious Diseases Public Health Food and Drug Administration (FDA)

DLA Piper

Food and Beverage News and Trends - January 2025 #2

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FDA issues proposed rule on front-of-package nutrition labeling. The FDA has released its proposed rule on front-of-package nutrition labeling which, if enacted, would add a requirement to include an informational box that...more

DLA Piper

Food and Beverage News and Trends - December 2024 #2

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This regular publication by DLA Piper lawyers focuses on helping clients navigate the ever-changing business, legal, and regulatory landscape. FSIS moving to strengthen oversight of food processing facilities with focus on...more

Holland & Knight LLP

What's In and Out for Healthcare in the Year-End Funding Package

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Lawmakers unveiled their long-awaited $1.7 trillion government funding package on Dec. 20, 2022. As of publishing, it seems likely that a vote on final passage in the U.S. Senate will occur at some point on Dec. 22, with a...more

Mintz - Health Care Viewpoints

FDA Is Accepting EUA Requests for Monkeypox Tests, But Time is of the Essence

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

Patrick Malone & Associates P.C. | DC Injury...

The U.S. summer of 2022: Infectious outbreaks and vital vaccines

In the 21st century, in the wealthiest and supposedly most advanced nation on the planet, infectious diseases and vaccines continue to be major part of the news headlines. Experts and regular folks are paying attention...more

Seyfarth Shaw LLP

Still Coughing: Now-Dominant COVID-19 Variant Can Elude Current Vaccines, Prompts FDA Action

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Seyfarth Synopsis: Omicron BA5 strain has become dominant and has evolved to render vaccinations and boosters less effective, resulting in many employers revisiting their COVID-19 policies....more

Knobbe Martens

U.S. FDA Approves Monkeypox Treatment Formulation

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(May 25, 2022) SIGA Technologies Inc., a New York-based pharmaceutical company, has received approval from the U.S. Food and Drug Administration (FDA) for an intravenous formulation of TPOXX (tecovirimat) for the treatment of...more

Goodwin

Draft Senate Legislation Expands FDA’s QIDP Designation

Goodwin on

On Tuesday, January 25, Senate Health, Education, Labor, and Pensions (HELP) Committee Chair, Senator Patty Murray (D-WA), and Ranking Member, Senator Richard Burr (R-NC) released a discussion draft of the Prepare for and...more

Hogan Lovells

PREVENT Pandemics Act to build pandemic capabilities and implications for medical product developers

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Earlier this week, the U.S. Senate HELP Committee released a discussion draft of the “Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act” (“PREVENT Pandemics Act”), a sweeping package broadly...more

Robinson+Cole Health Law Diagnosis

HHS Again Requires FDA Premarket Review for COVID-19 Tests

On Monday, November 15, 2021, the Food and Drug Administration (FDA) announced that the U.S. Department of Health and Human Services (HHS) repealed a policy established by the Trump administration that directed the FDA not to...more

Dorsey & Whitney LLP

Updates on Legal Challenges to Health Care Employers’ Voluntary COVID-19 Vaccine Mandates

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On May 28, 2021, a group of Houston Methodist Hospital employees filed a lawsuit challenging the hospital’s COVID-19 vaccine mandate for employees.  The lawsuit, filed by 117 employees, was the first to challenge a health...more

Faegre Drinker Biddle & Reath LLP

COVID-19 Weekly Newsletter: Booster Shots Continue To Gain Steam

Recent announcements on the prospect of booster shots for all vaccinated Americans, a vaccine mandate for staff at federally funded nursing homes and an encouraging uptick in vaccinations marked an eventful week in the...more

Faegre Drinker Biddle & Reath LLP

COVID-19 Weekly Newsletter: Formidable Delta Variant Prompts Vaccine Mandates

Vaccinated Individuals Infected With Delta Variant May Carry as Much Virus as Unvaccinated - The U.S. Centers for Disease Control and Prevention (CDC) updated their mask guidance on July 27, 2021, recommending that...more

ArentFox Schiff

Is Delta Taking Over?

ArentFox Schiff on

On February 24, 2021, we first reported on the most significant variants of the novel coronavirus then emerging across the globe and here in the United States. In that Alert, we included the prediction by the Centers for...more

Brownstein Hyatt Farber Schreck

Can Employers Mandate COVID-19 Vaccines? Likely Not (Yet), Given Current FDA Emergency Use Authorization Status

With distribution of COVID-19 vaccines moving ahead full-steam, an end to the pandemic may be in sight in the coming months. However, what is collectively known as the “new normal” still comes with a minefield of unanswered...more

Alston & Bird

Alston & Bird Health Care Week in Review - February 2021 #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

Faegre Drinker Biddle & Reath LLP

COVID-19 Weekly Newsletter: U.S. Suffers Deadliest Days for COVID-19

In an otherwise troubling week, there are some positive developments in the COVID-19 response, including progress in the development of a new vaccine. The Pandemic Is Far from Over: 4000 Lives Gone in One Day - ...more

Bricker Graydon LLP

Providers should account for extra doses of COVID-19 vaccines in their vaccination plans

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Ohio has been receiving shipments of COVID-19 vaccines since the U.S. Food and Drug Administration (FDA) granted authorization for emergency use in December 2020....more

Jackson Walker

Unpacking the COVID-19 Vaccine Distribution: A Bright Spot During a Dark Winter

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In the waning days of autumn, it appeared that Texas was destined for a dark winter. As recently as December 14, 2020, the Texas Department of State Health Services (DSHS) reported over 1.3 million confirmed cases of...more

Mintz - Health Care Viewpoints

FDA in 2020: What a Year!

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

Health Care Compliance Association (HCCA)

Report on Research Compliance Volume 17, Number 12. In This Month's E-News: December 2020

Report on Research Compliance 17, no. 12 (December 2020) - Finalizing a document issued last year, on Nov. 9 the Food and Drug Administration issued “Enhancing the Diversity of Clinical Trial Populations—Eligibility...more

Hogan Lovells

Coronavirus: The Hill and the Headlines, November 2020 # 7

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In Washington: The Centers for Disease Control and Prevention updated its guidance on face masks to say that masks not only protect others around you but also protects the wearer. The guidance clarifies that masks reduce...more

Hogan Lovells

Coronavirus: The Hill and the Headlines, October 2020 # 18

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In Washington: The Trump administration will pay Eli Lilly $375 million to supply 300,000 doses of its experimental antibody drug to treat COVID-19, the Department of Health and Human Services said Wednesday. If the Food and...more

Hogan Lovells

Coronavirus: The Hill and the Headlines, October 2020 # 10

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In Washington: State public health officials are urging Congress to provide at least $8.4 billion in emergency funding for distributing a coronavirus vaccine, warning that they lack enough money to carry out the immense...more

Womble Bond Dickinson

For Emergency Use Only?

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While requiring vaccinations for school attendance and in some occupations is common, the issue of employers requiring vaccination for COVID-19 is currently a hot topic. There is currently no Food and Drug Administration...more

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