Medical Device Legal News with Sam Bernstein: Episode 18
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 169: Shirley Paddock, Senior VP of Clinical Development, Syneos Health
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 168: Christine Harhaj, Senior Director of Advocacy & Strategic Alliances, PhRMA
Podcast: Unpacking FDA's Final Clinical Decision Support Guidance - Diagnosing Health Care
Podcast: Post-Dobbs - Considerations for Clinical Trials and Research - Diagnosing Health Care
Product Launching in the Era of COVID-19 - Diagnosing Health Care Podcast
JONES DAY PRESENTS® Digital Health and Clinical Research: Understanding Regulatory Regimes
JONES DAY PRESENTS® The Impact of Digital Health on Research and Clinical Trials
Nota Bene Episode 75: Clinical Trial Disclosures on the World Map with TrialScope Chief Strategy Officer Thomas Wicks
Podcast: Non-binding Guidance: SEC Disclosure Issues for Life Sciences Companies
Life Sciences Quarterly (Q3 2019): SEC Enforcement and Class Actions Regarding FDA Communications
Podcast: Non-binding Guidance: Real-World Evidence in Drug Development and FDA Submissions
Passage of Federal Right-to-Try law poses risks and opportunities for patients and the biopharmaceutical industry
Life Sciences Quarterly (Q4 2017): The Use of Social Media and Mobile Applications
A recent New York Times article reported that dozens of spine surgery patients at NewYork-Presbyterian/Weill Cornell Medical Center were treated with a product that was not approved for use in such procedures. Burst...more
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
Editor’s Note: In the autumn issue of the Clinical Research as a Care Option (CRAACO) newsletter, an interview with Manatt Health’s Donna O’Brien gives pharma readers insight into how hospitals view trials, some of the...more
The inclusion of racial and ethnic groups in clinical trials has been a national priority for decades, but progress toward that goal has been limited. When the COVID-19 pandemic threw into stark relief the underlying...more
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
Executive Summary - The inclusion of racial and ethnic groups in clinical trials has been a national priority for decades, but progress toward that end has been limited. When the Covid-19 pandemic threw into stark relief...more
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
Last month, The Economist published a call to action titled, “There is a worrying amount of fraud in medical research: And a worrying unwillingness to do anything about it.” The article is the latest in a sequence of alarms...more
In this episode, Rebecca Schaefer and Michael Hinckle review some types of hospital and health system activities that could trigger FDA regulatory oversight. They discuss the FDA’s jurisdiction over IRB’s in medical device...more
Global life sciences companies, research institutes, and universities face unique challenges when complying with U.S. and non-U.S. trade control laws, including complying with general and specific licenses authorizing...more
Report on Research Compliance 18, no. 9 (September, 2021) - A former Harvard Medical School and Massachusetts General Hospital (MGH) researcher who was the principal investigator on a 2014 NIH award of $939,495.27 and...more
Report on Research Compliance 18, no. 7 (July 2021) - In a review of more than 500 NIH awards, the HHS Office of Inspector General (OIG) found that about one-fifth were funded “out of rank order,” and for more than a...more
In Washington: With only hours to spare, House and Senate lawmakers were forced to pass a last-minute short-term extension of government funding (H.J. Res. 107) to stave off a government shutdown while congressional...more
Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in healthcare regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies, and...more
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
As healthcare providers and universities respond to the spread of COVID-19, legal counsel at these institutions should be prepared to assist their institution’s research enterprise in anticipating and reacting to any changes...more
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
What is Quality Anyways?: James Hinton, the CEO of Baylor Scott and White, got a good laugh from the audience when he said that he was proud to be one of the five or six hundred hospitals in the nation’s top 100 hospitals....more
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
On December 13, 2016, President Obama signed into law the 21st Century Cures Act (Act), one of the most important pieces of health care and life sciences legislation in several decades. The Act is intended to spur the rapid...more
Latest Healthcare False Claims Act Roundup and Top 3 Best Practices to Reduce Exposure - As the legal landscape in healthcare becomes increasingly complex, healthcare companies that receive federal program funds face...more
Trends & Analysis: ..We have identified 33 health care–related qui tam cases that have been unsealed in whole or in part since the cases covered in our last Qui Tam Update. In addition, we have also identified one case...more