News & Analysis as of

Food and Drug Administration (FDA) Healthcare Coronavirus/COVID-19

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

McDermott Will & Emery

Healthcare Regulatory Check-up Newsletter | April 2024 Recap

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This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for April 2024. We discuss several US Department of Health and Human Services (HHS) agency actions, including the Calendar Year (CY) 2025...more

Axinn, Veltrop & Harkrider LLP

Rethinking Interchangeability, Top Cases, and Battling Misinformation at FDLI’s Annual Conference

1 Last week, the Food and Drug Law Institute held its Annual Conference while also celebrating its 75th anniversary. There, members of FDA and industry players gathered to discuss the latest legal, policy, and regulatory...more

Troutman Pepper

Navigating the Future of Pharmacy Law: Key Takeaways From the 2023 American Society of Pharmacy Law Conference

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Earlier this month, the American Society of Pharmacy Law hosted its annual conference in San Antonio, TX. This gathering of industry leaders provided a unique opportunity to delve into the ever-evolving landscape of pharmacy...more

McDermott Will & Emery

Remote Monitoring and Digital Therapies: CMS Updates Coverage and Payment Policies

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In recent years, the Centers for Medicare & Medicaid Services (CMS) has expanded payment for remote monitoring services in an effort to pay for non-face-to-face services that improve care coordination for Medicare...more

McDermott+

McDermottPlus Check-Up: September 15, 2023

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CONGRESS - Senators Sanders and Marshall Release Bipartisan Primary Care and Health Workforce Act. Released on September 14, the legislation would reauthorize funding for a number of healthcare workforce programs that are...more

McDermott Will & Emery

FDA Issues Final Guidance on Informed Consent in Clinical Investigations

On August 15, 2023, the US Food and Drug Administration (FDA) finalized Informed Consent: Guidance for IRBs, Clinical Investigators, and Sponsors (final guidance). This document finalizes, with new examples and limited...more

Akin Gump Strauss Hauer & Feld LLP

10 Health Issues to Watch as Congress Returns from August Recess

Health care has been one of the most active issue areas in the 118th Congress. The activity by the health committees of jurisdiction in both the House and the Senate has been fueled in part by efforts to reauthorize various...more

Goldberg Segalla

FDA to EPA: Pump the Brakes on New EtO Rules During Supply Chain Shortage

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With COVID diagnoses spiking across the United States this summer, we cannot yet claim that the pandemic is behind us. In fact, we are still experiencing residual medical device and equipment shortages, which has caused...more

Manatt, Phelps & Phillips, LLP

Impact of the Pandemic and the End of the Public Health Emergency on Opioid Use Disorder Treatment

This report was written in partnership with and funded by the Foundation for Opioid Response Efforts. During the COVID-19 pandemic, the federal government and many states offered regulatory flexibilities intended to make...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

Gardner Law

Healthcare Enforcement in a Post-Pandemic World

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After a year-over-year reduction in drug, device, and biologic Warning Letters from 2012 through 2019, Warning Letters spiked to pre-2014 levels in 2020 during the pandemic. This was due in large part to a significant number...more

McDermott+

McDermottPlus Check-Up: May 19, 2023

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The House and Senate were both in session this week, with significant healthcare activity at the committee level. The House Ways & Means Committee met to discuss healthcare price transparency, and the Ways & Means Health...more

Knobbe Martens

FDA Issues Final Guidance on Transitioning from COVID-19 EUAs

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The FDA recently announced release of final transition guidance documents for medical diagnostic devices targeting COVID-19. The transition guidance documents are intended to guide COVID-19 diagnostic device manufactures as...more

Bass, Berry & Sims PLC

11th Annual Healthcare Fraud & Abuse Review 2022

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We are pleased to bring you our 11th annual Healthcare Fraud & Abuse Review. Our Review provides comprehensive coverage of the most significant civil and criminal enforcement issues facing healthcare providers. Each year, we...more

Foley & Lardner LLP

What’s Next in Washington? - September 2022 Edition

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As September gets underway and Washington returns from a busy recess, important deadlines loom. August saw the introduction and passage of the Inflation Reduction Act, the Biden Administration’s announcement of student debt...more

Clark Hill PLC

Window on Washington – Vol. 6, Issue 25

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Outlook for This Week in the Nation’s Capital - Congress. The House is in a committee work period this week, and the Senate is in recess....more

Mintz - Health Care Viewpoints

DOJ Announces Another Wide-Ranging COVID-19 Fraud Enforcement Action

For the last few years, we have been closely monitoring and reporting on COVID-19 related fraud enforcement efforts by federal agencies. We detailed those findings in our Health Care Enforcement 2020 Year in Review & 2021...more

Wilson Sonsini Goodrich & Rosati

DOJ Civil Division's Consumer Protection Branch Features FDA Enforcement Actions in its First-Ever Annual "Recent Highlights"...

Earlier this month, the U.S. Department of Justice (DOJ) Civil Division's Consumer Protection Branch (CPB) released its first-ever annual "recent highlights" report. The report describes the CPB's accomplishments from October...more

Bradley Arant Boult Cummings LLP

COVID and CBD Prove to be a Powder Keg for Federal Regulators

Cannabis operators (from marijuana to hemp-derived products such as CBD) often get the sense they are one of the central targets of the federal government’s reach. But they are not in the same league lately as the COVID-19...more

Alston & Bird

Alston & Bird Health Care Week in Review - February 2022 #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

Knobbe Martens

FDA Approval for Novel Medical Devices Remains a High Priority, Despite COVID-19

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In addition to its significant efforts to fast track the approval of COVID-19 related devices, the FDA’s Center for Devices and Radiological Health (CDRH) has also maintained its high priority focus on supporting innovation...more

Arnall Golden Gregory LLP

AGG Food & Drug Newsletter - January 2022

Arnall Golden Gregory LLP's Food & Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community and highlights articles from members of our Food & Drug practice, as well as from...more

Arnall Golden Gregory LLP

AGG Food & Drug Newsletter - December 2021

Arnall Golden Gregory LLP's Food & Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community and highlights articles from members of our Food & Drug practice, as well as from...more

Alston & Bird

FDA Authorizes Two Oral COVID-19 Drugs – Medical Products Supply Chain Week in Review

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In the past week, the FDA authorized Pfizer’s and Merck’s oral antivirals for the treatment of COVID-19. The Biden-Harris Administration released the Trucking Action Plan. The CDC endorsed ACIP recommendation of preference...more

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