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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

Health Care Compliance Association (HCCA)

Moffitt Center’s FCA Settlement is First of 2024; Questions Surround Nature of Billing Errors

Moffitt Cancer Center’s recent $19.5 million settlement with the U.S. Department of Justice (DOJ) and the state of Florida resolving allegations that billing errors violated the False Claims Act (FCA) triggered a “fully...more

ArentFox Schiff

ArentFox Schiff Issues the First Global Definitive Legal Guide for Industries Navigating AI

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Artificial intelligence promises to transform the way we live and work and its impact will undoubtedly stretch to every business sector across the globe. This next generation of technology brings exciting possibilities and...more

Husch Blackwell LLP

Analysis of U.S. Food and Drug Administration Draft Guidance on Clinical Trials with Psychedelic Drugs

Husch Blackwell LLP on

On June 23, 2023 the U.S. Food and Drug Administration (FDA) published a draft guidance document with foundational considerations for researchers that are developing psychedelic drugs for the treatment of medical conditions....more

Health Care Compliance Association (HCCA)

[Event] Healthcare Research Compliance Academy - December 13th - 16th, Las Vegas, NV

HCCA's Healthcare Research Compliance Academy is a three-and-a-half-day intensive training program designed to help attendees increase their ability to manage effective research compliance programs. Our faculty of experts...more

Vinson & Elkins LLP

Data Corruption: DOJ Targets Fraud In Medical Research Trial In The Era Of COVID-19

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In late 2019, Gustav Eyler, the Director of the U.S. Department of Justice’s (“DOJ”) Consumer Protection Branch (“CPB”), cited fraudulent data in clinical research trials for new drugs and medical devices as a topic of “major...more

Faegre Drinker Biddle & Reath LLP

COVID-19 Weekly Newsletter: Pharma Companies Sign Vaccine Pledge, Relief Package Stalls

AstraZeneca’s Phase 3 vaccine clinical trials came to a halt this week as the pharmaceutical company works to identify the underlying cause of a case of transverse myelitis emerging in a volunteer. The pause coincided with...more

Hogan Lovells

HHS offers flexibility on human subjects protection regs during COVID-19 pandemic

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On April 8, the U.S. Department of Health and Human Services’ (HHS) Office for Human Research Protections (OHRP) issued guidance discussing how HHS human subjects protection regulations....more

Faegre Drinker Biddle & Reath LLP

FDA Funding Opportunity Announcement: “Exploring the use of Real-World Data to Generate Real-World Evidence in Regulatory...

The U.S. Food & Drug Administration (FDA) has released a Funding Opportunity Announcement (FOA) titled “Exploring the use of Real-World Data to Generate Real-World Evidence in Regulatory Decision-Making (U01) Clinical Trials...more

Hogan Lovells

Clinical trials: Digital technology for recruitment, consent, and data capture

Hogan Lovells on

The conduct of clinical trials still relies heavily on the use of paper documents. Of course, electronic case report forms (eCRF) have been commonly used for many years – the medical information on a patient that is...more

A&O Shearman

CRISPR Therapeutics Announces Two-Year Collaboration Agreement with Massachusetts General Hospital

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CRISPR Therapeutics and Massachusetts General Hospital Cancer Center (MGHCC) have entered into a two-year research collaboration and license option agreement to develop novel T-cell therapies for cancer. CRISPR/Cas9 gene...more

A&O Shearman

Human Germline Genome Editing – Genetics bodies weigh in on debate with position paper

A&O Shearman on

In an article published in American Journal of Human Genetics on 3 August 2017, an international group of 11 organisations with genetics expertise has issued a joint position statement, setting out 3 key positions on the...more

Akerman LLP - Health Law Rx

Social Media Use for Clinical Trial Recruitment

Social media can be an effective and easy way to connect with friends and professional contacts. However, it can also serve as a tool for institutions and principal investigators involved in enrolling subjects in clinical...more

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