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
On August 6, 2024, the Food and Drug Administration (FDA) partnered with the Clinical Trials Transformation Initiative (CTTI) to hold a joint, public workshop titled, “Artificial Intelligence (AI) in Drug & Biological Product...more
On June 26, 2024, the U.S. Food and Drug Administration (FDA) issued draft guidance setting forth detailed requirements for the submission of Diversity Action Plans (DAPs) by sponsors of certain clinical studies involving...more
The United States occupies a leadership position in clinical advancements, in terms of pharmaceuticals, medical devices, innovative care processes and interventional techniques. At the nexus of these advances are clinical...more
While economic factors, including the high cost of capital, continue to keep our clients up at night, we also see signs of optimism in 2024. Against this fiscal backdrop, significant recent regulatory changes and those on the...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
Life sciences companies engaged in early development programs face a number of strategic considerations, such as where and how to administer the early stage scientific studies and each phase of clinical trials that are needed...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
Recorded at NC Life Sciences Organization’s 2023 annual meeting, hosts Heather and Matthew welcome Christine Harhaj, the Senior Director for Pharmaceutical Research and Manufacturers of America (PhRMA). They have an...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
After almost a decade, the Food and Drug Administration (FDA or Agency) finalized the Informed Consent guidance document (Final Guidance). The Final Guidance finalizes the 2014 draft Informed Consent Information Sheet...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
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
Artificial intelligence (AI) is rapidly transforming the life sciences industry, with significant advancements in various areas. These innovations bring new legal challenges related to intellectual property, data protection,...more
The U.S. Food and Drug Administration (FDA or the Agency) has issued the final guidance document, “Informed Consent: Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors” (Final Guidance). The...more
Over the past five years, cell and gene therapies have increasingly moved from the R&D pipeline to the health care setting, putting lifesaving treatments for certain cancers and genetic diseases within patients’ reach. Over...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
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
Last week, the U.S. Food and Drug Administration (FDA) issued draft guidance on Good Clinical Practice (GCP), adopting the International Council for Harmonisation’s (ICH) “E6(R3)” guidelines. Below we summarize how the draft...more
On May 2, 2023, the U.S. Food and Drug Administration (FDA) took additional steps to support the use of decentralized clinical trials (DCTs) by releasing a new draft guidance titled “Decentralized Clinical Trials for Drugs,...more
Over the past few years, the life sciences and healthcare industries have experienced a notable increase in focus and interest in decentralized clinical trials (DCTs), in which some or all of the trial-related activities...more
On May 2, 2023, the U.S. Food and Drug Administration (“FDA”) published draft guidance titled “Decentralized Clinical Trials for Drugs, Biological Products, and Devices” (the “Draft Guidance”). ...more
Clinical trials are an essential component of the research architecture for developing new drugs and devices. Research institutions and their clinical investigators (“Investigators”) play an important role in supporting drug...more
The privacy landscape in the United States and much of the world is quickly evolving around the framework of the General Data Protection Regulation (GDPR) within the European Economic Alliance (EEA). Clinical trials involve...more