News & Analysis as of

Prescription Drugs CARES Act Pharmaceutical Industry

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

Bass, Berry & Sims PLC on

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

K&L Gates LLP

New FDA Draft Guidance Aiming To Prevent Drug Shortages Will Affect Pharmaceutical Manufacturers

K&L Gates LLP on

The U.S. Food and Drug Administration (FDA) has taken formal steps to prevent and mitigate drug shortages for over a decade. While the problem predates the COVID-19 pandemic, the pandemic presented potential new challenges...more

Hogan Lovells

FDA urges drug makers to establish risk management plans to reduce drug shortages Managing supply chain risks is prudent, even if...

Hogan Lovells on

On May 19, the U.S. Food and Drug Administration (FDA or the Agency) published the draft guidance “Risk Management Plans to Mitigate the Potential for Drug Shortages,” which aims to assist drug manufacturers in complying with...more

Arnall Golden Gregory LLP

The Room Where It Happens: FDA Issues Draft Guidance on Formal Meetings Between FDA and Sponsors of OTC Monograph Drugs

The Food and Drug Administration let sponsors and requestors of over-the-counter (“OTC”) monograph drugs know how to be in the room where it happens when it issued a draft guidance this month on “Formal Meetings Between FDA...more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

Hogan Lovells

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

Hogan Lovells on

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

Akin Gump Strauss Hauer & Feld LLP

What's New in Washington - September 2020

As the November elections rapidly approach, Congress faces a number of key legislative deadlines, including the need to fund federal agencies and extend expiring federal programs at the conclusion of the current fiscal year...more

Mintz - Health Care Viewpoints

OTC Monograph Reform: Key Takeaways and What Industry Can Expect

On March 27, 2020, the President signed into law the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), which in part describes reforms to modernize the regulatory framework for over-the-counter (OTC) monograph...more

White & Case LLP

Impact of the CARES Act on the Pharmaceutical and Medical Devices Industries

White & Case LLP on

On March 27, 2020, the President signed the Coronavirus Aid, Relief, and Economic Security (“CARES”) Act. The purpose of the CARES Act is to provide emergency assistance and health care response for individuals, families, and...more

Morgan Lewis

CARES Act Provisions Impact Drug, Device, and Food Manufacturers and Suppliers

Morgan Lewis on

The $2 trillion economic stimulus package laid out in the Coronavirus Aid, Relief, and Economic Security (CARES) Act includes $11 billion in appropriations for vaccines, therapeutics, and other medical needs, and $34.9...more

Skadden, Arps, Slate, Meagher & Flom LLP

CARES Act Provides Much-Needed Stimulus for U.S. Businesses, Individuals

On March 27, 2020, Congress approved the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) to provide financial assistance to individuals and businesses, which in aggregate greatly exceeds the financial package...more

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