News & Analysis as of

Clinical Trials Physicians

Downs Rachlin Martin PLLC

Mass General Brigham study offers promise that nasal spray targeting neuroinflammation could become an effective treatment for TBI

The secondary cascade, although a normal physiological response, can contribute to ongoing neuroinflammation, oxidative stress and axonal injury, continuing in some cases years after the initial insult.  There is no clearly...more

Bass, Berry & Sims PLC

Healthcare Trends & Transactions Q1 2025

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The healthcare mergers and acquisitions (M&A) market began 2025 with a slower start than expected given the easing headwinds and building momentum at the end of last year, with the number of deals reported in Q1 lower than...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

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

Foley & Lardner LLP

Artificial Intelligence: Is the Health Care Sector Ready for the Rollout?

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On July 17, 2024, Foley & Lardner LLP hosted the Boston Health Care AI & Technology Investor Summit with Endeavor Venture Funds, bringing together hundreds of attendees in person and virtually to discuss issues surrounding...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

Husch Blackwell LLP

Ketamine Clinics: Five Legal Considerations for Psychedelic-Assisted Psychotherapists

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Amid the growing interest in psychedelic-assisted psychotherapy, especially with substances like MDMA, psilocybin, and ketamine, it becomes imperative to navigate the intricate landscape of legal considerations associated...more

Health Care Compliance Association (HCCA)

[Event] 2023 Healthcare Enforcement Compliance Conference - November 5th - 7th, Washington, DC

Hear directly from the enforcement community - Want to gain insight into properly monitoring, detecting, investigating, and managing violations? Join us at HCCA’s Annual Healthcare Enforcement Compliance Conference to...more

Health Care Compliance Association (HCCA)

Fake Histories, Calls by Staff Impersonating Subjects: A Look Inside Two Trial Fraud Cases

Report on Research Compliance 19, no. 2 (January 27, 2022) - The trial was to be like any other that the clinical research organization (CRO) would oversee. The six-month study, known as VESTRI, would involve pediatric...more

Holland & Knight LLP

Podcast - Talking Sickle Cell Trait with NFL Wide Receiver Ty Montgomery and Dr. Anjulika Chawla, MD, FAAP

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In honor of National Sickle Cell Awareness Month, Holland & Knight's Public Policy & Regulation Group is proud to partner with the Black Women's Health Imperative for a four-part podcast series on sickle cell disease. Sickle...more

Health Care Compliance Association (HCCA)

[Virtual Event] Hawaii Regional Healthcare Compliance Conference - October 7th, 7:55 am - 4:00 pm HST

Our Virtual Regional Healthcare Compliance Conferences provide updates on the latest news in regulatory requirement, compliance enforcement, and strategies to develop effective compliance programs. Watch, listen, and ask...more

Health Care Compliance Association (HCCA)

[Virtual Event] 2021 Research Compliance Conference - June 14th - 16th, 9:00 am - 5:00 pm CDT

Attend HCCA’s annual Research Compliance Conference to receive the latest insights and guidance on emerging research compliance risks and solutions. This virtual event, held June 14 – 16, will be live and interactive. Learn...more

Health Care Compliance Association (HCCA)

Florida medical doctor pleads guilty to conspiring to falsify clinical trial data

Compliance Today (March 2021) - According to a recent U.S. Department of Justice news release, Yvelice Villaman Bencosme, a Miami, Florida, doctor and the primary investigator for clinical trials designed to investigate...more

Bricker Graydon LLP

Florida pediatrician pleads guilty to conspiring to falsify clinical trial data in research study for asthma medication for...

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On January 8, 2021, the Department of Justice announced that a Miami, Florida pediatrician pleaded guilty to one count of wire fraud in connection with a clinical research study of an asthma medication for children. ...more

Health Care Compliance Association (HCCA)

[Virtual Event] 2021 Regional Healthcare Compliance Conference - Alaska - February 25th, 8:25 am - 4:30 pm AKST

Our Virtual Regional Healthcare Compliance Conferences provide updates on the latest news in regulatory requirement, compliance enforcement, and strategies to develop effective compliance programs. Watch, listen, and ask...more

Health Care Compliance Association (HCCA)

Report on Research Compliance Volume 17, Number 12. In This Month's E-News: December 2020

Report on Research Compliance 17, no. 12 (December 2020) - Finalizing a document issued last year, on Nov. 9 the Food and Drug Administration issued “Enhancing the Diversity of Clinical Trial Populations—Eligibility...more

Epstein Becker & Green

Product Launching in the Era of COVID-19 - Diagnosing Health Care Podcast

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This Diagnosing Health Care episode looks at the adjustments to business operations and compliance programs that pharmaceutical and medical device companies need to consider as they launch new products during the ongoing...more

Bass, Berry & Sims PLC

Significant Change to ClinicalTrials.gov Reporting Requirements: Ten Years' Worth of Back Data Owed

The National Institutes of Health (NIH) has warned clinical trial sponsors – including not only drug and device companies, but also universities and hospitals with investigator-initiated trials – to submit significant...more

Society of Corporate Compliance and Ethics...

[Event] Regional Compliance & Ethics Conference - February 27th - 28th, Anchorage, AK

This two-day Regional Compliance and Ethics Conferences provide attendees with a forum to interact with local compliance professionals, share information about your compliance successes and challenges, and create educational...more

ArentFox Schiff

Investigations Newsletter: Manufacturer to Pay Over $37.5 Million to Resolve False Claims Act Allegations

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DOJ News - Manufacturer to Pay Over $37.5 Million to Resolve False Claims Act Allegations - On January 15, 2015, the DOJ announced that ResMed Corp., a manufacturer of durable medical equipment, agreed to pay over...more

Epstein Becker & Green

7 Hot Health Care Industry Sectors for Investment, Growth & Consolidation in 2020

Based on their extensive experience advising health care industry clients, Epstein Becker Green attorneys and strategic advisors from EBG Advisors are predicting the “hot” health care sectors for investment, growth, and...more

Searcy Denney Scarola Barnhart & Shipley

Is the FDA Broken? — Uloric Cardiac Risk Issues

Was Uloric Approval the Safe Decision? Attempts in 2005 and 2006 to obtain government-approval to sell Uloric were denied by the FDA due to concerns about research data that showed a slight elevation in the risks of death...more

Holland & Knight LLP

Right to Try Law Enacted by Congress: Implementation Unclear

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On May 30, 2018, President Trump signed the Trickett Wendler, Frank Mongiello, Jordan McLinn and Matthew Bellina Right to Try Act of 2018. The bill allows the provision of certain unapproved, investigational drugs to patients...more

Holland & Knight LLP

FDA Announces Modernization of Drug Review Process and Operations

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On June 4, 2018, the Food and Drug Administration (FDA) announced a major restructuring in its Office of New Drugs (OND) within the Center for Drug Evaluation and Research (CDER). OND currently includes six offices with 19...more

Verrill

"Right to Try" Comes to the Federal Stage: What Stakeholders Should Do Now

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On May 30, 2018, surrounded by patients directly impacted by tragic and intractable diseases, President Trump signed into law the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017...more

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