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Coronavirus/COVID-19 › Prescription Drugs

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 -
Goodwin

European Commission Approves Moderna’s Updated COVID-19 Vaccine

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On July 30, 2025, Moderna announced that the European Commission (EC) granted marketing authorization for the updated formulation of Moderna’s COVID-19 vaccine Spikevax®.  The updated vaccine targets the LP.8.1 variant of...more

ArentFox Schiff

Investigations Newsletter: Johnson & Johnson Challenges the Constitutionality of FCA $1.6 Billion Verdict

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Johnson & Johnson Challenges the Constitutionality of FCA $1.6 Billion Verdict - Following a record $1.6 billion jury verdict for off-label promotion of HIV drugs Prezista and Intelence, Johnson & Johnson (J&J) subsidiary...more

Warner Norcross + Judd

Insights from the Largest DOJ Health Care Fraud Enforcement Effort in U.S. History

Warner Norcross + Judd on

On June 30, the Department of Justice (DOJ) announced the largest coordinated health care fraud enforcement effort in U.S. history, involving criminal charges against over 300 defendants and over $14.6 billion in health care...more

Goodwin

FDA Approves BLA for Novavax’s COVID-19 Vaccine

Goodwin on

On May 19, Novavax, Inc. (“Novavax”) announced that FDA approved its Biologics License Application (“BLA”) for Nuvaxovid™ for active immunization against COVID-19 in adults 65 years and older and individuals 12 through 64...more

Rivkin Radler LLP

DEA Announces New Telemedicine Rules Expanding Access to Controlled Substances

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On January 16, the U.S. Drug Enforcement Administration (DEA) announced three new telemedicine rules that extend prescribing flexibilities for controlled substances, following the expiration of temporary flexibilities granted...more

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

Better Health Care Newsletter - February 2025

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Long before Christians in ancient Rome venerated Valentine and designated the priest-physician as the patron saint of lovers, the Greeks had studied humanity’s varied affection for members of our species. The ancients defined...more

McDermott+

DEA Releases Long-Awaited Telehealth Special Registration Proposal, but Adoption Is Uncertain

McDermott+ on

On January 15, 2025, the US Drug Enforcement Administration (DEA) released a proposed rule entitled Special Registrations for Telemedicine and Limited State Telemedicine Registrations. This proposed rule would establish three...more

Smart & Biggar

Agile licensing amendments registered

Smart & Biggar on

Following consultation starting in 2022, on November 29, 2024, Regulations Amending Certain Regulations Made Under the Food and Drugs Act (Agile Licensing) were registered. These Regulations amend the Food and Drug...more

Alston & Bird

Health Care Week in Review: Biden Administration Submits Disaster Aid Request; Senators Propose New Health Care Cybersecurity...

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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

Dinsmore & Shohl LLP

DEA Further Extends Telemedicine Prescribing Flexibilities through December 2025

Dinsmore & Shohl LLP on

The Drug Enforcement Administration (DEA) is once again extending telemedicine prescribing flexibilities for controlled substances. This latest extension, which is now the third extension of such flexibilities originally...more

McDermott Will & Schulte

DEA Extends Telemedicine Flexibilities for Controlled Substance Prescribing Through December 31, 2025

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The US Drug Enforcement Administration (DEA) further extended flexibilities that allow providers to prescribe controlled substances via telemedicine without first performing an in-person visit. The flexibilities were...more

Robinson+Cole Health Law Diagnosis

DEA Extends Telehealth Lifeline for Patients

Robinson+Cole Health Law Diagnosis on

On November 15, 2024, the Drug Enforcement Administration (DEA) and the Department of Health & Human Services (HHS) jointly announced an extension of current COVID-era tele-prescribing flexibilities for another year – through...more

Ropes & Gray LLP

Hospital and Health Systems Reimbursement Check - NOVEMBER 2024

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Ropes & Gray attorneys share their analysis of administrative and court litigation, regulatory developments, key developments affecting federal program payments to hospitals and health systems, and other reimbursement-related...more

Rivkin Radler LLP

Court: Mailing Drugs to Patients’ Homes is a Potential Stark Law Violation

Rivkin Radler LLP on

A recently issued federal court opinion confirmed that certain pre-COVID era prescribing restrictions are back in place. In July 2023, a nonprofit advocacy group, Community Oncology Alliance, filed suit against the U.S....more

McDermott+

Pending DEA Extension on Prescription of Controlled Substances via Telemedicine

McDermott+ on

A new rule posted on the Office of Management and Budget (OMB) registry suggests that the Drug Enforcement Administration (DEA) is planning an additional extension of COVID-19 flexibilities for telemedicine prescribing of...more

Sands Anderson PC

Vaccination Injury is a Matter of Time

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If you believe you were injured by any of the 16 vaccines covered under the National Vaccine Injury Compensation Program you must have symptoms of the claimed injury lasting at least six months to be able to file a claim for...more

Goodwin

FDA Approves Moderna’s and Pfizer/BioNTech’s Updated COVID-19 Vaccines

Goodwin on

On August 22, Moderna announced that FDA approved its supplemental Biologics License Application (“sBLA”) for a new formula of their COVID-19 vaccine, SPIKEVAX®, for individuals 12 years old and above. Emergency Use...more

Goodwin

FDA Platform Technology Draft Guidance Highlights Utility of Obscure Patent Term Extension Provision

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As discussed in a prior Goodwin Alert, the US Food and Drug Administration (FDA) recently released Draft Guidance for designating a platform technology for drug development pursuant to § 560k of the Federal Food, Drug, and...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

ArentFox Schiff

Investigations Newsletter: Chicago Laboratory Owner Charged with Defrauding Medicare in $60 Million COVID-19 Test Kit Scheme

ArentFox Schiff on

Chicago Laboratory Owner Charged with Defrauding Medicare in $60 Million COVID-19 Test Kit Scheme - The Chicago-based owner of two laboratories, Zoom Labs Inc. and Western Labs Co., has been charged with health care fraud...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

McDermott+

Exploring the Virtual Care Policy Landscape One Year Post-PHE

McDermott+ on

May 11, 2024, marked one year since the end of the COVID-19 public health emergency (PHE), and not much has changed in Medicare telehealth policy. We are still operating under temporary waivers and flexibilities and, as a...more

McCarter & English, LLP

New Jersey Regulatory Update Part I

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It is that time of year for our regulatory update. Parts I and II will discuss proposed and adopted rules from the second half of last year to the first quarter of this year that impact healthcare providers in New Jersey,...more

Foley Hoag LLP

Healthcare Issues to Watch Following the FY2024 Spending Deal

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Six months into the fiscal year, Congress has finally passed FY2024 appropriations. It was a painstaking process, which many expected to include policy victories that both sides could celebrate. Instead, the spring work...more

Goodwin

SAMHSA Final Rule Codifies Opioid Treatment Program Telehealth and Take-Home Medication Flexibilities

Goodwin on

On February 2, 2024, the Department of Health and Human Services (HHS) issued a Final Rule that expands access to medications for the treatment of opioid use disorder (OUD) via telehealth modalities and “take-home” doses....more

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