News & Analysis as of

Clinical Trials 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

Maynard Nexsen

Episode 230: Innovations in Cancer Treatment with Dr. Ray DuBois of MUSC Hollings Center

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Recorded at SCbio’s 2025 annual conference, Heather and Lauren welcome Dr. Ray DuBois, a physician and researcher who has dedicated his life to cancer research and patient-centered care. Dr. DuBois, Director of MUSC’s...more

Goodwin

Securities Litigation Against Life Sciences Companies 2024 Year in Review

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Welcome to our ninth annual report on US securities class actions filed against publicly traded life sciences companies, which include pharmaceutical, biotechnology, medical device, and healthcare companies....more

Health Care Compliance Association (HCCA)

[Event] Healthcare Research Compliance Academy - March 24th - 27th, Chicago, IL

HCCA's Healthcare Research Compliance Academy is a three-and-a-half-day interactive educational program with a focus on the highly specialized and complex regulations and issues that affect research compliance professionals....more

Benesch

Dialysis & Nephrology Digest - February 2025

Benesch on

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

Health Care Compliance Association (HCCA)

[Event] Research Compliance Conference - June 2nd - 4th, Orlando, FL

Get the latest insights in research compliance - The risks and challenges that come with clinical research are unique, as are the abundance of government regulations and enforcers that oversee them. HCCA’s Research...more

American Conference Institute (ACI)

[Event] 2nd Annual Life Sciences AI Summit - February 20th - 21st, New York, NY

Gain firsthand insights from leading in-house experts on the transformative power of AI in the life sciences at ACI's 2nd Annual Life Sciences AI Summit. Discover strategies to navigate the complex legal and regulatory...more

Ropes & Gray LLP

FDA and OHRP Issue Draft Guidance on Including Biopsies in Clinical Trials

Ropes & Gray LLP on

On January 6, 2025, the U.S. Food and Drug Administration (“FDA”) and the Office for Human Research Protections (“OHRP”) issued a joint draft guidance on including tissue biopsies in clinical trials that evaluate...more

Alston & Bird

Health Care Week in Review: CMS Releases Advance Notice of MA and Part D Payment Methodologies and Senate Finance Chair Identifies...

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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

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

McGuireWoods LLP

Recent FDA Guidance Signals Future Growth for Decentralized Clinical Trials

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On Sept. 18, 2024, the U.S. Food & Drug Administration (FDA) issued a final guidance document titled “Conducting Clinical Trials With Decentralized Elements, Guidance for Industry, Investigators, and Other Interested...more

Foley & Lardner LLP

Decentralized Clinical Trials: Research Misconduct Risks & How to Avoid Them

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This is the fifth edition of our blog series on decentralized clinical trials DCTs. Click here to explore the series. The COVID-19 Pandemic required the health care industry to adapt to accommodate remote patient care,...more

Alston & Bird

Health Care Week in Review: House Energy & Commerce Committee Held a Markup of 16 Bills; HRSA Demands Johnson & Johnson Cease 340B...

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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

Health Care Compliance Association (HCCA)

[Virtual Event] Research Compliance Conference - November 12th, 8:00 am - 5:00 pm CT

Stay on top of developments in healthcare research compliance - Whether you missed the 2024 in-person Higher Education & Healthcare Research Compliance Conference in New Orleans, or are looking for additional insights...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

McDermott Will & Schulte

Pharma and MedTech Services Investment Summit 2024

The inaugural Pharma and MedTech Services Investment Summit brought together C-suite executives, senior private equity professionals, investment bankers and other industry leaders for a deep dive into the investment...more

Holland & Knight LLP

Holland & Knight Health Dose: July 9, 2024

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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., impacting the health sector....more

Holland & Knight LLP

Holland & Knight Health Dose: April 24, 2024

Holland & Knight LLP on

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., impacting the health sector. This week's topics include...more

McDermott Will & Schulte

[Event] Pharma and MedTech Services Investment Summit 2024 - May 2nd, San Francisco, CA

YOUR SOURCE FOR SUCCESS IN PHARMA AND DEVICE SERVICES INVESTING - Join C-suite executives, senior private equity professionals, investment bankers and other industry leaders for a deep dive into the investment...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

Foley & Lardner LLP

Clinical Research: FDA Issues Draft Guidance on Informed Consent

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The U.S. Food and Drug Administration (FDA), in collaboration other agencies, recently published draft guidance (Guidance) on effectively presenting key information regarding informed consent in FDA-regulated clinical...more

Society of Corporate Compliance and Ethics...

[Event] Higher Education & Healthcare Research Compliance Conference - June 10th - 12th, New Orleans, LA

Don’t miss our annual conference devoted to higher education and research compliance - Attend the Higher Education & Healthcare Research Compliance Conference June 10–12, 2024 and hear from experienced professionals on a...more

Holland & Knight LLP

Holland & Knight Health Dose: February 27, 2024

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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., impacting the health sector....more

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