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2024 is shaping up to be a very active year for regulatory and enforcement developments in the healthcare industry
Mintz
Madison said, "Looking at the historical context of why pregnant women are excluded from these studies is important,"
referencing a period when the use of thalidomide by pregnant people to treat nausea...
Mintz
These sweeping final rules finalized many changes that were introduced in the Proposed 2025 Rules and other changes that were proposed in the Proposed 2024 Rules.
Goodwin Procter LLP
On April 16, Alvotech and Teva announced the FDA approval of SELARSDI™ (ustekinumab-aekn), biosimilar to Johnson and Johnson's STELERA® (ustekinumab).
Goodwin Procter LLP
As we previously reported, the U.S. Department of Justice ("DOJ") filed a lawsuit under the Anti-Kickback Statute against Regeneron Pharmaceuticals in the District of Massachusetts...
Goodwin Procter LLP
As we previously reported, trial in Regeneron Pharmaceutical, Inc.'s BPCIA case against Mylan Pharmaceuticals Inc. and Biocon Biologics, Inc. (collectively, "the Biocon Defendants")...
Foley & Lardner
In its November 2023 Proposed Rule and in its recently issued Final Rule that was published in the Federal Register on April 23, 2024, the Centers for Medicare & Medicaid Services (CMS)...
Goodwin Procter LLP
On April 15, 2024, Fresenius Kabi announced the U.S. launch of its ACTEMRA biosimilar, TYENNE (tocilizumab-aazg) as an intravenous formulation.
Crowell & Moring LLP
The Federal Trade Commission (FTC) recently entered into a settlement with Monument, Inc., an alcohol addiction treatment service, ...
Exponent
On March 15, the Food and Drug Administration issued new draft guidance that impacts premarket submissions for all medical devices that produce temperature changes in patient tissues...
Mintz
The government's continued dedication of resources to investigating and prosecuting fraud against COVID-19 pandemic relief programs appears to have borne fruit according to the results of the COVID-19 ...
Holland & Knight
In this episode of "Counsel That Cares," healthcare attorney Jesse Neil examines the unique challenges and strategic options facing public hospitals...
Perkins Coie LLP
The Washington State Supreme Court significantly expanded the scope of potential hospital tort liability for the allegedly negligent actions of nonemployee, independently contracted emergency room service physicians...
Exponent
On Nov. 17, the Food and Drug Administration released the final guidance for assessing the credibility of computational modeling and simulation (CM&S) in medical device submissions.
Jones Day
In February 2024, the Department of Justice ("DOJ") announced the results of its 2023 False Claims Act ("FCA") enforcement efforts.
Holland & Knight
"Informed consent" has been described as "a bedrock principle of healthcare in a free society," and if a "patient is denied the ability to exercise or even consider informed consent, the patient's personal liberty suffers."
Exponent
Updates on conducting a toxicological risk assessment of medical device extractable and leachable constituents for FDA submissions
Exponent
Four questions for developing inclusive digital solutions by identifying women-specific requirements and endpoints
Bass, Berry & Sims
The Bass, Berry & Sims Healthcare Private Equity Team is pleased to share with you our first installment of the BBS Connect Newsletter for 2024.
Ankura Consulting Group LLC
The Health Insurance Portability and Accountability Act (HIPAA) mandates stringent protections for the privacy and security of protected health information (PHI).
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