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Coronavirus/COVID-19 › CARES Act › Pharmaceutical Industry

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 -
ArentFox Schiff

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

ArentFox Schiff on

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

Bass, Berry & Sims PLC

12th Annual Healthcare Fraud & Abuse Review - A Critical Resource for Healthcare Providers

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We are pleased to bring you our 12th 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

Bass, Berry & Sims PLC

11th Annual Healthcare Fraud & Abuse Review 2022

Bass, Berry & Sims PLC on

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

Hogan Lovells

Coronavirus: The Hill and the Headlines, June 2021

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In Washington: Senate Parliamentarian Elizabeth MacDonough has ruled that the Senate can only discharge one more automatic budget reconciliation this year, upending Democrat’s strategy to sidestep Republicans in advancing...more

ArentFox Schiff

FDA Announces New Fees for Manufacturers of Over-the-Counter Drugs

ArentFox Schiff on

As we explained in a previous alert, one of the lesser-known provisions of the March 2020 Coronavirus Aid, Relief, and Economic Security (CARES) Act was a significant overhaul of the way that most OTC drugs are regulated in...more

Womble Bond Dickinson

FDA Reissues Notice Announcing Increased OTC Monograph Facility Fees

Womble Bond Dickinson on

On March 26, 2021, the FDA updated and reissued the fee rates for the newly created over-the-counter (OTC) monograph Drug User Fee program (OMFUA) for FY2021 in a Federal Register Notice (FRN) titled “Fee Rates under the...more

MoFo Life Sciences

Vaccine Production And State Intervention In The U.S.

MoFo Life Sciences on

During the COVID-19 pandemic, governments across the globe have become increasingly involved in the private sector. State-owned enterprises have long been common in Asia, but the pandemic has increased their prominence in...more

Sheppard Mullin Richter & Hampton LLP

FDA Announces Facility Fees for OTC Drug Manufacturers

Sheppard Mullin Richter & Hampton LLP on

On Friday, March 26, 2021, FDA published a Federal Register notice, “Fee rates under the Over-The-Counter Monograph Drug User Fee Program for Fiscal Year 2021,” announcing 2021 fee rates under its over-the-counter (OTC)...more

Bass, Berry & Sims PLC

Healthcare Fraud & Abuse Review 2020

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Ensuring compliance with the False Claims Act has never been more important for healthcare providers. By March 2020, we saw healthcare professionals standing at the forefront of one of the greatest health crises in a...more

Mintz - Health Care Viewpoints

Recent Amendments to the FDA Laws Attempt to Clarify and Improve Existing Systems

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Although the Biden-Harris Administration that assumed control of the Executive Branch on January 20, 2021 immediately ordered a regulatory freeze of new or pending rules while the new administration gets its bearings, several...more

Pillsbury Winthrop Shaw Pittman LLP

Congressional and Government Investigations in 2021: What to Expect from the Biden-Harris Administration and How to Prepare

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As savvy investigators in Congress and the Biden-Harris Administration prepare for new and expanded government investigations, it is time for potential targets to assess and address their vulnerabilities. Investigators in...more

Hogan Lovells

Coronavirus: The Hill and the Headlines, January 2021 # 8

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In Washington: The House voted 232-197 to impeach President Trump for a second time on a charge of inciting insurrection over the Jan. 6 siege on the U.S. Capitol that left five people, including a Capitol Police officer,...more

Goodwin

President Signs Consolidated Appropriations Act Including Biosimilars Related Provisions

Goodwin on

On December 27, the President signed the Consolidated Appropriations Act, which includes two provisions relevant to biosimilars: First, Section 322 of Division BB permits but does not require aBLAs to include information...more

American Conference Institute (ACI)

[Virtual Event] 8th Annual Advanced Forum on False Claims and Qui Tam Enforcement - March 24th - 25th, 8:15 am - 4:45 pm...

American Conference Institute (ACI) on

THE ONLY EVENT WHERE YOU'LL HEAR FROM Government, In-house Counsel, The Judiciary, the Defense & Relator’s Bar - ACI’s 8th Annual Advanced Forum on False Claims and Qui Tam Enforcement will address the underlying...more

Faegre Drinker Biddle & Reath LLP

COVID-19 Weekly Newsletter: Vaccine Progress Report

Faegre Drinker Biddle & Reath LLP on

As countries in the Western Hemisphere prepare for the first shipments of vaccines, researchers continue to release new COVID-19 findings. Vaccine News Galore! U.K. Approves COVID-19 Vaccine, Ahead in the Western World:...more

Polsinelli

DOJ Creates National Rapid Responce Strike Force As Focus On Health Care Fraud Continues To Grow

Polsinelli on

As COVID-19 continues to ravage the United States, the Department of Justice (DOJ) has recently announced its new National Rapid Response Strike Force within the Health Care Fraud Unit to investigate and prosecute fraud cases...more

Hogan Lovells

COVID-19 Report for Life Sciences and Health Care Companies (UPDATED)

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Tuesday, 24 November 2020 - U.S. President-elect Joe Biden has pledged to expand the role of the federal government in response to the COVID-19 public health emergency, build on the Affordable Care Act, and continue drug...more

Fox Rothschild LLP

Key Steps The Pharma And Bioscience Sectors Must Take Ahead Of Federal Scrutiny Of COVID-19 Relief Funding

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An unprecedented explosion of government investigation and enforcement is at hand as federal regulators focus their efforts on ferreting out any fraud or abuse of the $1 trillion in COVID-19 relief funding programs through...more

WilmerHale

Decoupling From China: Part 3 - Oversight And The Election

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The COVID-19 pandemic and the serious supply chain vulnerabilities it exposed have led to a seismic shift in U.S. policy and regulation, from stepped-up measures to protect U.S. technology, intellectual property and data from...more

Polsinelli

DOJ Creates National Rapid Response Strike Force As Focus on Health Care Fraud Continues to Grow

Polsinelli on

As COVID-19 continues to ravage the United States, the Department of Justice (DOJ) has recently announced its new National Rapid Response Strike Force within the Health Care Fraud Unit to investigate and prosecute fraud cases...more

Jones Day

Vital Signs: Digital Health Law Update | Summer 2020

Jones Day on

Note From the Editors - With this Summer 2020 issue of Vital Signs, we take a moment to again applaud the remarkable actions of all the health care and life science organizations around the globe working tirelessly on our...more

WilmerHale

COVID-19: Healthcare Fraud in a Public Health Emergency

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This is the third in a series of client alerts addressing the likely role of the False Claims Act in the wake of the massive federal government response to the COVID-19 pandemic. The healthcare industry is no stranger to...more

Hogan Lovells

Coronavirus: The Hill and the Headlines – COVID-19 D.C. Update – June 2020 #12

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In Washington: The Small Business Administration (SBA) said it resumed accepting applications yesterday from small businesses for a disaster-aid program, known as the Economic Injury Disaster Loan program....more

Hogan Lovells

Coronavirus: The Hill and the Headlines – COVID-19 D.C. Update – May 2020 #12

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In Washington: Sen. Debbie Stabenow (D-MI) and Senate Minority Leader Chuck Schumer (D-NY) will be launching a messaging campaign on “the cost of Republican inaction during the COVID-19 crisis.”  Schumer said President...more

Tarter Krinsky & Drogin LLP

FDA Issues Guidance Related To CARES Act Amendments For Medical Device Manufacturers

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The U.S. Food and Drug Administration (FDA) recently published new guidance (the Guidance) related to actual or potential medical device shortages during the COVID-19 pandemic The Guidance is meant to implement Section 506J...more

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