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
As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape....more
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
The Bioresearch Monitoring (BIMO) Program, operated by the U.S. Food and Drug Administration (FDA), conducts on-site inspections and data audits in order to effectively monitor the compliance of all FDA-regulated research....more
In a decision that issued last week, a Patent Trial and Appeal Board (“PTAB”) panel instituted inter partes review (“IPR”) of a petition filed by Merck Sharp & Dohme LLC (“Merck”) for a patent owned by The Johns Hopkins...more
Some funding applications submitted to NIH beginning Jan. 25 will face new requirements and undergo a revised peer review process. To prepare investigators and institutions, NIH launched a dedicated website with details about...more
Readers of this newsletter know we’re big fans of high-quality medical research. Well-designed, statistically robust studies have saved lives, changed medical practice, and made the world a better place....more
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
On March 1, 2024, the US Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP) and the US Food & Drug Administration (FDA) unveiled a preliminary guidance document named Enhancing...more
Earlier this month, the U.S. Food and Drug Administration (“FDA”) issued a draft guidance, “Key Information and Facilitating Understanding in Informed Consent”, with notable implications for clinical trial sponsors,...more
On March 1, 2024, the US Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP) and the US Food & Drug Administration (FDA) released a draft guidance document entitled Key Information and...more
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
EXECUTIVE SUMMARY - Clinical trials are a lifesaving option for many cancer patients. But too many patients face barriers preventing access to this critical treatment. Everyone suffers when patients cannot access...more
HCCA's Healthcare Research Compliance Academy is a three-and-a-half-day comprehensive training program with a focus on the topics and issues that affect research compliance professionals. Our faculty of experienced...more
Report on Research Compliance 20, no. 11 (November, 2023) City University of New York (CUNY ) has accused neuroscientist Hoau-Yan Wang, a CUNY faculty member and longtime collaborator with embattled biotech firm Cassava...more
On August 15, 2023, the US Food and Drug Administration (FDA) finalized Informed Consent: Guidance for IRBs, Clinical Investigators, and Sponsors (final guidance). This document finalizes, with new examples and limited...more
On August 15, 2023, the U.S. Food and Drug Administration (“FDA”) released final guidance on informed consent for clinical investigations (“Final Guidance”). This update follows FDA’s draft guidance, which was issued in July...more
Wellness claims are everywhere. Do they work? Ah, wellness! Such a positive word! Such a noble aspiration for all of us! And such an opportunity for hucksters, hokum and high jinks in the eternal battle to separate...more
Get the latest strategies and insights for healthcare research compliance - Whether you missed this year’s in-person Research Compliance Conference or are looking for additional insights from research colleagues and...more
In this episode, Michael Hinckle and Rebecca Schaefer provide an overview of FDA’s recently issued draft guidance on decentralized clinical trials. They review the goals of the guidance to promote diversity in clinical...more
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
U.S. President Biden recently enacted the “Consolidated Appropriations Act, 2023,” a $1.7 trillion omnibus funding bill that contains the Food and Drug Omnibus Reform Act (FDORA). Below we analyze how Section 3612 of FDORA,...more
Speakers From AbbVie, National Institutes of Health, National Organization for Rare Disorders, NYU Grossman School of Medicine and Verily Share Insights on How Medical Innovation Is Disrupting Policy—and What Needs to Come...more
HCCA's Healthcare Research Compliance Academy is a three-and-a-half-day comprehensive training program designed to help attendees increase their ability to manage effective compliance programs. Our faculty of experts provides...more
The Council on Governmental Relations (COGR) is sounding an alarm regarding costs institutions have expended to comply with “new and clarified provisions calling for researchers to disclose all sources of research support and...more
Perspectives on Life Sciences Webinar Series: Explore Key Life Sciences Issues at the Intersection of Law, Policy & Business Strategy - Although increasing representation of underserved populations in clinical trials has...more