News & Analysis as of

Public Health Department of Health and Human Services (HHS) Food and Drug Administration (FDA)

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

Alston & Bird

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

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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

Jackson Lewis P.C.

Department of Justice Publishes Notice of Proposed Rulemaking to Reschedule Marijuana to Schedule III

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The Department of Justice (DOJ) published a Notice of Proposed Rulemaking to reschedule marijuana from Schedule I to Schedule III of the federal Controlled Substances Act (CSA) in the Federal Register on May 21, 2024. If the...more

Alston & Bird

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

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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

King & Spalding

FDA Publishes White Paper on Artificial Intelligence & Medical Products

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On March 15, 2024, FDA published a white paper titled “Artificial Intelligence & Medical Products: How CBER, CDER, CDRH, and OCP are Working Together” (the AI White Paper) on the use of artificial intelligence (AI) across the...more

Alston & Bird

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

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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

Troutman Pepper

Inside FDA’s Response to Reagan-Udall Foundation Report: Spotlight on the Public Education Campaigns and Resources Task Forces

Troutman Pepper on

This is the fifth post in our multipart series evaluating the Food and Drug Administration’s (FDA’s) response to the Reagan-Udall Foundation report (the Report) on the operations of the Center for Tobacco Products (CTP). If...more

Dorsey & Whitney LLP

HHS and FDA Take Additional Measures to Aid Post-PHE Transition for Pharmacy Providers

Dorsey & Whitney LLP on

For the last three years, the federal government has taken considerable steps to aid providers in the fight against COVID-19. Although many of the waivers and flexibilities initiated in response to the pandemic have since...more

Goodwin

The Long (Un)Winding Road, Part 2: The FDA’s Final Transition Guidances for COVID-19 Devices

Goodwin on

In early 2023, the Biden administration announced and set into motion its plans to wind down a number of pandemic-related programs and allow the COVID-19 public health emergency (PHE) declaration, which has been in effect...more

Alston & Bird

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

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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

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

Holland & Knight LLP

Indian Country Impacted by National Strategy on Hunger, Nutrition and Health

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The White House released its National Strategy on Hunger, Nutrition, and Health on Sept. 27, 2022, ahead of the second-ever White House Conference on Hunger, Nutrition, and Health. Specifically, the 44-page paper calls on...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

MoFo Life Sciences

New Opportunities For Test Developers: Monkeypox Diagnostics

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For in vitro diagnostic test developers, the monkeypox public health emergency presents an urgent public health need for testing as well as a unique opportunity for rapid regulatory review of testing products....more

King & Spalding

White House’s FY 2023 Budget Request Includes Healthcare Provisions

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President Biden submitted his Fiscal Year (FY) 2023 budget request to Congress on March 28, 2022. The budget request is not binding on Congress. Rather, it may serve as a guide for both Congress and the administration as they...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

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

Alston & Bird

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

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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

Alston & Bird

Alston & Bird Health Care Week in Review - April 2021 #3

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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

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

Arnall Golden Gregory LLP

OTC Monograph Reform – Takeaways from FDA’s Webinar on Expedited Administrative Orders

On January 27, 2021, the Food and Drug Administration held its second webinar since the enactment of the Coronavirus Aid, Relief and Economic Security Act (the CARES Act) in March 2020, to further discuss over-the-counter...more

Alston & Bird

Alston & Bird Health Care Week in Review - February 2021 #2

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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

King & Spalding

Final Rule Requires Retrospective Review of HHS Regulations

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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

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

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