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Alston & Bird

Health Care Week in Review: Donald Trump Wins 2024 Presidential Election; Republicans May Control Both Senate and House of...

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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

Alston & Bird

Health Care Week in Review: HHS Released Final Guidance for the Second Cycle of Medicare Drug Price Negotiations; CMS Released...

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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

Foley & Lardner LLP

Decentralized Clinical Trials: Research Misconduct Risks & How to Avoid Them

Foley & Lardner LLP on

This is the fifth edition of our blog series on decentralized clinical trials DCTs. Click here to explore the series. The COVID-19 Pandemic required the health care industry to adapt to accommodate remote patient care,...more

McDermott Will & Emery

FDA Gives Companies a New Way to Fight Misinformation

McDermott Will & Emery on

Misinformation shared by independent third parties presents a significant public health concern because it can lead patients and healthcare providers to forgo treatments that are safe and effective or choose treatments that...more

Alston & Bird

Health Care Week in Review: House Committee on Oversight and Accountability Held a Hearing on PBMs; HHS Reorganizes Technology,...

Alston & Bird on

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

Alston & Bird

Health Care Week in Review: House Held a Markup of 23 Bills; Senators Announced a Proposal on Primary Care Payment Reform

Alston & Bird on

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

Alston & Bird

Health Care Week in Review: House Passes Appropriations Bill and Senate Expected to Vote Shortly, CMS Unveils the ACO Primary Care...

Alston & Bird on

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

Axinn, Veltrop & Harkrider LLP

FDA Tackles AI . . . and Other Digital Health Technologies

FDA announced on October 11, 2023 that it is creating a new Digital Health Advisory Committee to provide guidance to FDA on issues relating to digital health technologies ("DHTs"), including artificial intelligence,...more

Alston & Bird

Health Care Week in Review: President’s Budget and ASPR Cybersecurity Guide

Alston & Bird on

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

Holland & Knight LLP

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

Holland & Knight LLP on

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

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

Better Healthcare Newsletter from Patrick Malone - October 2021

Two of the leading killers of Americans have one preventable cause in common. Many, many cases of lung cancer and cardiovascular diseases are caused by tobacco abuse. Medical scientists long ago proved this beyond a doubt....more

Dorsey & Whitney LLP

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

Dorsey & Whitney LLP on

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

Alston & Bird

Alston & Bird Health Care Week in Review - May 2021 #1

Alston & Bird on

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

Alston & Bird

Alston & Bird Health Care Week in Review - February 2021 #4

Alston & Bird on

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

King & Spalding

Final Rule Requires Retrospective Review of HHS Regulations

King & Spalding on

Last week, HHS issued a final rule setting expiration dates for regulations that are not retrospectively reviewed in a timely manner. The final rule requires HHS to review its regulations every 10 years to determine whether...more

Bricker Graydon LLP

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

Bricker Graydon LLP on

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

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

[Webinar] Looking ahead to 2021: Impacts of the election for the life sciences and health care industry - November 19th, 12:30 pm...

Hogan Lovells on

Life Sciences and Health Care Horizons virtual event series - The fast pace of innovation in the life sciences and health care industry has reached an all-time high in 2020 as the industry grapples with the new reality of...more

Manatt, Phelps & Phillips, LLP

COVID-19 Vaccine Distribution: National Academies Framework Aims to Inform Federal & State Planning

A Framework for Equitable Allocation of COVID-19 Vaccine was published on Friday by the National Academies of the Sciences, Engineering, and Medicine (NASEM) to guide ongoing vaccine planning efforts by federal, state, and...more

Alston & Bird

Alston & Bird Health Care Week in Review - August 2020 #4

Alston & Bird on

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

McDermott Will & Emery

[Webinar] Around the Corner: Evolving Opportunities and Challenges for Real-World Evidence and Data-Powered Solutions - August...

McDermott Will & Emery on

Healthcare research has faced severe disruption during the COVID-19 public health emergency and underscored the need for novel technological solutions that harness and utilize data beyond traditional clinical research models....more

McDermott Will & Emery

Detailed Summary of Federal Requirements for Production of Hand Sanitizing Products

To meet the growing need for hand sanitizing products, various federal agencies including the Alcohol Tobacco Tax and Trade Bureau (TTB), Federal Drug Administration (FDA), Health and Human Services (HHS) and Congress have...more

Seyfarth Shaw LLP

FDA Eases Enforcement to Help Make More Ventilators Available

Seyfarth Shaw LLP on

The U.S. Food and Drug Administration (the “FDA”) issued Guidance[1] on March 22, 2020 to continue its efforts to maintain an adequate supply of devices to treat patients who develop respiratory failure or respiratory...more

K&L Gates LLP

COVID-19: K&L Gates Triage: FDA Facilitates Diagnostic Testing and Heightens Public Safety Efforts Amid Outbreak

K&L Gates LLP on

In this week’s episode, Kenneth Kennedy discusses several of FDA’s strategies for helping stakeholders in the drug and medical device industry support health care providers in their fight against the COVID-19 outbreak. In...more

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