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Coronavirus/COVID-19 › Public Health › Food and Drug Administration (FDA)

Read guidance, analysis, and updates on the myriad issues arising from the global response to the COVID-19 pandemic. Updated hourly every day, the insights published here are written by leading lawyers and law firms... more +
Read guidance, analysis, and updates on the myriad issues arising from the global response to the COVID-19 pandemic. Updated hourly every day, the insights published here are written by leading lawyers and law firms helping to make sense of insurance, employment, tax, securities, M&A, risk management, and every other consideration touched by this crisis. Follow the channel for a daily email brief of the latest and best updates. less -
McGuireWoods Consulting

Health Care Executive Orders And Legal Actions: Part Three

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Public Health - Withdrawing from the World Health Organization (WHO)...more

Holland & Knight LLP

Two Days, Two Hearings: NIH and FDA Nominees Go Before the HELP Committee

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Dr. Jayanta (Jay) Bhattacharya, nominated to be Director of the National Institutes of Health (NIH), and Dr. Martin Makary, nominated to be the Commissioner of the U.S. Food and Drug Administration (FDA), appeared before the...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

Sheppard Mullin Richter & Hampton LLP

FDA Dumps Trio of Device-Related Guidances Prior to Administration Change

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Among the wave of guidance documents issued by the U.S. Food and Drug Administration (“FDA” or the “Agency”) in the first week of 2025 were three notable draft guidance documents pertaining to medical devices (together, the...more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

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

Paul Hastings LLP

Post-COVID Checkup: Current FDA Due Diligence Considerations

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The COVID-19 pandemic highlighted both the incredible promise and challenges for life science companies developing and manufacturing drugs, biological products, and devices that enhance our lives....more

Knobbe Martens

FDA Updates Medical Device Shortages List

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The FDA has updated its Medical Device Shortages List to remove Specimen Collection, Laboratory Reagents and Testing Supplies, Transport Media Device, Saline Vascular Access Flush, and Certain Ventilation-Related Products....more

Dorsey & Whitney LLP

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

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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

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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

McDermott Will & Emery

Special Report - 2022 FDA Year in Review

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As the United States’ primary public health and consumer protection agency, the US Food and Drug Administration (FDA) regulates at least one quarter of the nation’s economy and exerts significant influence over global...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

Regulatory Roundup: Important FDA Developments at the End of September 2022

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There were so many interesting and significant developments related to the various missions of the U.S. Food and Drug Administration (FDA) during the last week or so of September 2022 that we decided to create a summary...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

Clark Hill PLC

Window on Washington – Vol. 6, Issue 32

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Outlook for This Week in the Nation’s Capital - Congress. The House and Senate are both in recess until Labor Day. Once they return, they will have a packed to-do list ahead of the November elections, which may include...more

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

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

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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

MoFo Life Sciences

FDA Will Once Again Accept Pre-Submissions For All In Vitro Diagnostic Tests

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The U.S. Food and Drug Administration (FDA) released a statement on May 31, 2022, that its Center for Devices and Radiological Health (CDRH) will once again be accepting all pre-submissions for all in vitro diagnostic (IVD)...more

MoFo Life Sciences

FDA Releases Draft Guidance On Digital Health Technologies For Remote Data Acquisition In Clinical Investigations

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In response to COVID-19 pandemic, the U.S. Food and Drug Administration (FDA) continues to work in support of clinical investigation sponsors and an evolving environment in which they run their clinical trials while...more

Goodwin

Draft Senate Legislation Expands FDA’s QIDP Designation

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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

Foley & Lardner LLP

Senate HELP Committee’s PREVENT Pandemics Act Draft Released: What to Know

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Following nearly a year of committee hearings, research, policy briefs, and discussion with agency experts, the Senate Health, Education, Labor, and Pensions (HELP) Committee Chairwoman Patty Murray (D-WA) and Ranking Member...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

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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

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

Kids now can get Covid shots. Will they? And what about the new anti-Covid pills?

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Even as the coronavirus batters parts of the country, notably the Mountain West, public health officials are pointing to key ways in which Americans could safely and effectively further quell the pandemic that has claimed...more

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