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Axinn Veltrop & Harkrider
Turning 40 is a big milestone for most of us. When I turned 40 – I won't tell you how long ago that was – I was knee-deep in Paragraph IV...
Wolf Popper
A surprise medical bill is one received by an insured patient for services rendered by a health care provider, or in a medical facility, that is out-of-network to that patient's insurance plan, ...
Nossaman LLP
Almost two years ago, the American Academy of Emergency Medicine Physician Group (AAEM-PG) filed suit in the Superior Court of California against Envision Healthcare Corporation (Envision).
After a long wait, the U.S. Food and Drug Administration (FDA) recently published a Final Rule to harmonize the Quality System Regulation (QSR) codified at 21 C.F.R. Part 820...
Contract development and manufacturing organizations (CDMOs) play a critical role in the pharmaceutical and biotech industries.
Polsinelli LLP
On February 6, 2024, the Federal Trade Commission ("FTC") commented in support of what would be a historic expansion of government march-in rights under the Bayh-Dole Act...
Ropes & Gray LLP
On December 21, 2023, the U.S. Food and Drug Administration ("FDA") published a final rule to allow institutional review boards ("IRBs") to waive or alter informed consent for certain clinical...
Sheppard Mullin Richter & Hampton
Welcome to Health-e Law, Sheppard Mullin's podcast exploring the fascinating health-tech topics and trends of the day. Our digital health legal team, alongside brilliant experts and thought leaders...
McGuireWoods LLP
Cara Reymann is the chief executive officer of First Fertility, which helps patients on their fertility journey through fertility practices and centers across the country.
Polsinelli LLP
On February 8, 2024, the U.S. Department of Health and Human Services, through its Office for Civil Rights (OCR)...
Jones Day
Mindy Hatton of the American Hospital Association reflects on the origins and goals of AHA's Hospitals Against Violence Initiative and its collaboration with Jones Day to fight human trafficking from a health care perspective.
Holland & Knight
Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings...
Sheppard Mullin Richter & Hampton
Delaware-based ChristianaCare Health System recently agreed to pay $47.1 million to resolve a lawsuit filed by the system's former chief compliance officer, Ronald Sherman.
Crowley Law LLC
Last week I had the opportunity to attend the BioMedical Engineering Day at Stevens Institute of Technology in Hoboken, New Jersey.
Manatt, Phelps & Phillips LLP
Last week, the Department of Health and Human Services (HHS) released a final rule intended to implement a 2020 modification to the federal substance use disorder (SUD) privacy statute.
Greenberg Traurig, LLP
In its latest global regulatory harmonization effort, on Feb. 2, 2024, the FDA published a final rule amending the cGMP requirements for medical devices contained in the QSR...
Wiley Rein
Health Care was a hot topic in the U.S. Senate on February 8, as two important Senate Committees – the Committee on Finance and the Committee on Health...
Steptoe LLP
In Part 13 of our StepLadder Series, we discussed the US Food and Drug Administration's (FDA) regulation of adhesives used in food-contact applications.
Axinn Veltrop & Harkrider
Can a drug manufacturer refuse to provide samples of its innovator product under the CREATES Act if it thinks that the requester will not actually use them to develop a biosimilar...
Arnold & Porter
This digest covers key virtual and digital health regulatory and public policy developments during January 2024 from the United States, United Kingdom, and European Union.
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