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McDonald Hopkins
Each year, the Executive War College provides valuable information for everyone in the lab industry. The McDonald Hopkins Healthcare team monitors trending topics discussed at the conference...
Perkins Coie LLP
USDA's Agricultural Marketing Service (USDA-AMS) recently published a Request for Information soliciting stakeholder input on the electronic or digital link disclosure option for bioengineered...
Kramer Levin Naftalis & Frankel LLP
On July 28, 2021, the Food and Drug Administration (FDA) approved the first interchangeable biosimilar product...
Manatt, Phelps & Phillips LLP
Abortion is a safe and an essential health care service. For over twenty years, medication has been used for abortion care safely during the first trimester through the use of two medications...
Hall Benefits Law
The U.S. Department of Labor (DOL) recently filed suit against the Blue Cross and Blue Shield of Minnesota (BCBSM), alleging various violations...
Bass, Berry & Sims
Despite the recent downward trend in DOJ healthcare industry settlements, the first quarter of 2024 saw many noteworthy False Claims Act (FCA) and civil healthcare fraud settlements...
Dickinson Wright PLLC
Carolyn Johnsen's article was recently published by the Arizona Society of Healthcare Attorneys titled "Distress in Health Care - Risk and Remedy."
Holland & Knight
Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C.,..
Akin Gump Strauss Hauer & Feld LLP
On April 4, the Centers for Medicare & Medicaid Services (CMS) released the Contract Year (CY) 2025 Medicare Advantage (MA) and Medicare Part D Policy and Technical Changes final rule ("Final Rule")...
Akin Gump Strauss Hauer & Feld LLP
The upcoming election, and the approaching end of the President's four-year term, introduce additional dynamics into the agencies' rulemaking process and even the guidance process.
Manatt, Phelps & Phillips LLP
The purpose of this quarterly tracker is to identify key federal and state health AI policy activity. Below reflects federal legislative and regulatory activity to date related to AI...
Buchanan Ingersoll & Rooney PC
Recent reports from the Centers for Disease Control and Prevention (CDC) and Food and Drug Administration (FDA) have brought to light a concerning development for those in the aesthetic...
Venable LLP
According to an April 2024 press release, Alvotech and Teva's Selarsdi™ (ustekinumab-aekn) was approved by the FDA on April 16 as a biosimilar of Janssen / Johnson & Johnson's Stelara® (ustekinumab).
Ogletree, Deakins, Nash, Smoak & Stewart
The U.S. Department of Justice's (DOJ) April 24, 2024, publication of its final rule on website accessibility for state and local governments under Title II of the Americans...
Manatt, Phelps & Phillips LLP
On January 18, 2024, the Center for Medicare and Medicaid Innovation (CMMI) at the Centers for Medicare and Medicaid Services (CMS) announced Innovations in Behavioral Health (IBH)...
Foley & Lardner
The U.S. Food and Drug Administration (FDA) recently doubled down on its January 26, 2023 position that existing regulatory pathways for foods and dietary supplements are not appropriate to manage...
Foley & Lardner
The Office of Inspector General (OIG) recently issued a new favorable advisory opinion regarding patient assistance programs (PAP) for 12 specific disease funds. PAPs help patients pay high cost-sharing...
Bass, Berry & Sims
The Centers for Medicare & Medicaid Services (CMS) recently proposed the Transforming Episode Accountability Model (TEAM) – a new, mandatory...
Sheppard Mullin Richter & Hampton
On April 2, the FDA issued a warning letter to Agena Bioscience Inc., alleging its product, intended for research use only (RUO)...
Arnold & Porter
This digest covers key virtual and digital health regulatory and public policy developments during March and early April 2024 from the United States, United Kingdom, and European Union.
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