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Clinical Trials Healthcare Health Care Providers

Smart & Biggar

Health Canada must redetermine exemption requests for psilocybin (magic mushroom)-assisted psychotherapy training

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TheraPsil, a patient advocacy organization, and 73 healthcare practitioners (HCPs) have succeeded in the Federal Court of Appeal (FCA) to overturn the refusal of the Minister of Mental Health and Addictions and Associate...more

Jones Day

Vital Signs: Digital Health Law Update | Spring 2025

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Welcome to Vital Signs, a curated compilation of the latest legal and regulatory developments in digital health....more

Benesch

Dialysis & Nephrology Digest - February 2025

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A New Hope in Kidney Transplants: The Promise of Xenotransplantation - Joe’s struggle for a kidney transplant highlights a dire reality: donor shortages are leaving countless patients in limbo. Enter Dr. PK, a pioneering...more

Jones Day

Vital Signs: Digital Health Law Update | Fall-Winter 2024

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We bring you Vital Signs, a curated, one-stop resource on the most notable digital health law updates from our U.S. and global contributors. In Industry Insights, we present a timely discussion about increasing litigation and...more

Husch Blackwell LLP

The Overturning of Chevron Deference: Implications for AI in Medical Research

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In a landmark decision on June 28, 2024, the Supreme Court overturned a 40-year-old legal precedent known as Chevron deference. Established in 1984, Chevron deference mandated that judges defer to federal agencies concerning...more

McDermott Will & Schulte

Key Takeaways | Clinical Trial Site Management Organizations (SMOs)

During this session, the panelists discussed the role that SMOs and dedicated clinical trial sites (Site Platforms) play within the life sciences industry, what makes them attractive to investors, and the key criteria...more

Health Care Compliance Association (HCCA)

‘If Only She Could Have Been Stronger’: Miami Trial Fraud Leads to Prison, Personal Loss

In September 2015, while working in an office on the grounds of Mercy Hospital in Miami, Ivette Maria Portela Martinez learned about an upcoming clinical trial for treatment of symptoms of Clostridium difficile infections and...more

Hogan Lovells

The “Borne Mission” Report analysis: Between hope and disappointment for the pharmaceutical industries

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Borne's long-awaited Report on regulation of healthcare products has fallen well short of pharmaceutical industry expectations. Indeed, it contains very few concrete proposals. ...more

McDermott Will & Schulte

Five Key Considerations for Study Pre-Screening and Recruitment Initiatives in the Digital Age

Key players across the healthcare industry—including sponsors, contract research organizations (CROs), research sites, regulators and patient advocates—are well aware of the challenges associated with the prompt and effective...more

Alston & Bird

Health Care Week In Review: CMS and HHS Issue Proposed Rules

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Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

King & Spalding

CMS Proposes National Coverage Decision For CAR-T Cancer Therapy

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On February 15, 2019, CMS released a proposal to provide nationwide coverage for a new cancer therapy, Chimeric Antigen Receptor T-cell Therapy (CAR-T Therapy), for Medicare patients. The proposed nationwide coverage decision...more

Wilson Sonsini Goodrich & Rosati

What You Need to Know About the Right to Try Act and Patient Access to Experimental Drugs

Recently, President Donald Trump signed into law the Right to Try Act of 2018 (RTTA).1 The RTTA represents the federal version of laws previously passed by a majority of the states, but with important differences. This WSGR...more

Ballard Spahr LLP

Obama Signs 21st Century Cures Act, Adding $6.3 Billion For Medical Research

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The Cures Act aims to increase the speed by which new drugs are brought to market by streamlining clinical trials, allowing the use of patient data in the regulatory review process, and modernizing U.S. Food and Drug...more

Foley & Lardner LLP

Navigating the Diagnostic Commercialization Process

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Guest Post By: Perry Dimas, Senior Vice President and General Manager for Premier Source, part of AmerisourceBergen The 2015 Business of Personalized Medicine Summit was an inspiring day with talented professionals. One...more

Faegre Drinker Biddle & Reath LLP

Bill Would Extend CMPs to Federal Grants

The bill known as the “21st Century Cures,” H.R.6, would extend Civil Monetary Penalties (CMPs) to cover false claims and false statements relating to grants, contracts, and other agreements funded by the Department of Health...more

King & Spalding

Also In The News - Health Headlines - April 2015 #4

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CMS Announces Round 1 2017 DMEPOS Competitive Bidding System – On April 21, 2015, CMS announced plans for a new bidding process for the supplier contracts awarded in the Round 1 Recompete of the DMEPOS Competitive Bidding...more

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