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Healthcare Pharmaceutical Industry New Regulations

Epstein Becker & Green

Medical Diagnostic Equipment Accessibility Regulations Announced by DOJ Under Title II of ADA

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To honor the 34th anniversary of the Americans with Disabilities Act (ADA), on July 26, 2024, the U.S. Department of Justice (DOJ) signed a long-awaited final rule to improve access to medical diagnostic equipment (MDE) for...more

Stikeman Elliott LLP

Regulatory Amendments Impacting Drug and Medical Device Recalls Coming Into Force

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On December 17, 2024, recent amendments to the Food and Drug Regulations (FDR) and the Medical Devices Regulations (MDR) relating to the recall of drugs and medical devices will come into force....more

Spilman Thomas & Battle, PLLC

The Health Record - Healthcare Law Insights, Issue 3, July 2024

Welcome to our third issue of The Health Record - our healthcare law insights e-newsletter! We are winding down the summer with our talented group of law students and they have continued to research and write, shadow...more

McDermott Will & Emery

Trending in Telehealth: June 11 – 17, 2024

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Trending in Telehealth highlights state legislative and regulatory developments that impact the healthcare providers, telehealth and digital health companies, pharmacists and technology companies that deliver and facilitate...more

McDermott Will & Emery

Trending in Telehealth: May 21 – May 27, 2024

Trending in Telehealth highlights state legislative and regulatory developments that impact the healthcare providers, telehealth and digital health companies, pharmacists and technology companies that deliver and facilitate...more

Knobbe Martens

New Ethylene Oxide Regulations may Raise Cost of Sterilization

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Last week, the Environmental Protection Agency (EPA) announced new regulations to reduce ethylene oxide emissions. According to the EPA’s press release, the new regulations are “the strongest measures in U.S. history to...more

Foley Hoag LLP - White Collar Law &...

Congressional Investigations: A Review of Investigations Likely to Continue in 2024 and into the 119th Congress

This is the sixth in our 2024 Year in Preview series examining important trends in white collar law and investigations in the coming year. We will be posting further installments in the series throughout the next several...more

McDermott Will & Emery

Trending in Telehealth: February 12 – February 26, 2024

Trending in Telehealth highlights state legislative and regulatory developments that impact the healthcare providers, telehealth and digital health companies, pharmacists and technology companies that deliver and facilitate...more

Troutman Pepper

Virginia Advances Toward New Medical Cannabis License Application With New Regulations

Troutman Pepper on

The Virginia Cannabis Control Authority (CCA), which assumed oversight of Virginia’s medical cannabis program from the Board of Pharmacy as of January 1, has promulgated regulations to govern medical cannabis operations in...more

McDermott Will & Emery

Trending in Telehealth: January 4 – 15, 2024

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Trending in Telehealth highlights state legislative and regulatory developments that impact the healthcare providers, telehealth and digital health companies, pharmacists and technology companies that deliver and facilitate...more

McDermott Will & Emery

Trending in Telehealth: September 19 – 25, 2023

McDermott Will & Emery on

Trending in Telehealth highlights state legislative and regulatory developments that impact the healthcare providers, telehealth and digital health companies, pharmacists and technology companies that deliver and facilitate...more

Akerman LLP

Florida's Prescription Drug Reform Act: What's in it for Florida Pharmacies?

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The Florida legislature took aim at pharmacy benefit managers (PBMs) during the 2023 legislative session by enacting the Prescription Drug Reform Act, Chapter 2023-29, Laws of Florida (https://laws.flrules.org/2023/29) (the...more

McDermott+

McDermottPlus Check-Up: May 19, 2023

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The House and Senate were both in session this week, with significant healthcare activity at the committee level. The House Ways & Means Committee met to discuss healthcare price transparency, and the Ways & Means Health...more

American Conference Institute (ACI)

Tips for Entering the Life Sciences Market in Brazil

For life sciences companies, Brazil’s market offers both an abundance of business opportunities and a myriad of on-the-ground regulatory compliance challenges for new entrants. Getting the market-entry strategy right will...more

Quarles & Brady LLP

Ohio Board of Pharmacy Formalizes a Pathway for Approval of Innovative Pharmacy Arrangements

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Effective March 11, 2022, Ohio Board of Pharmacy (“Board”) enacted a new regulation, Ohio Admin. Code 4729:5-3-20, that creates a procedure for licensees to petition the Board for approval of pilot or research projects...more

Morgan Lewis

HRSA Publishes Orphan Drug Rule for 340B Program

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Rule requires most manufacturers to change government pricing methodologies, calculations, and systems. On July 23, the Health Resources and Services Administration (HRSA) of the U.S. Department of Health and Human...more

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