Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 247: Reimagining Cell Therapy for Solid Tumors with Ming-Wei Chen and Fangheng Zhou of RephImmune
Taking the Pulse: A Health Care and Life Sciences Video Podcast | Episode 235: Revolutionizing Cancer Care with Eric Perrault of Kiyatec
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 234: Life-Saving Collaboration in the Life Sciences Industry with John Crowley, President & CEO of BIO
Episode 230: Innovations in Cancer Treatment with Dr. Ray DuBois of MUSC Hollings Center
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
Podcast - Talking Sickle Cell Trait with NFL Wide Receiver Ty Montgomery and Dr. Anjulika Chawla, MD, FAAP
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 July 10, 2025, citing a drive to increase transparency, the Food and Drug Administration (“FDA”) published more than 200 complete response letters (CRLs) previously issued to companies that had submitted new drug...more
In the latest episode of Health Law Diagnosed , Of Counsel Bridgette Keller hosts a discussion of best practices for interacting and communicating with the FDA. Hear from Joanne Hawana and Ben Zegarelli, FDA specialists...more
Ropes & Gray recently hosted its Third Annual Ropes & Gray Rare Disease Forum on May 1, 2025 in Cambridge, Massachusetts. The event gathered legal, commercial, and patient advocacy experts in the rare disease community to...more
The Food and Drug Administration (FDA) recently announced that it had identified “significant data integrity and study conduct concerns” with bioequivalence studies conducted by the India-based contract research organization...more
When the Food and Drug Administration’s Office of Prescription Drug Promotion (“OPDP”) issued a recent Notice of Violation (“NOV”), some of us were humming, “Let’s get clinical,” to the tune of Olivia Newton-John’s 1982 hit...more
DTC Telehealth Platforms - Arrangements involving telemedicine and direct-to-consumer (“DTC”) business services are expected to be a source of major regulatory scrutiny. In 2024, such arrangements were the focus of proposed...more
Applied Therapeutics, a clinical-stage biopharmaceutical company, is under heightened scrutiny following the issuance of a November 2024 Warning Letter from the US Food and Drug Administration (FDA) on the heels of a routine...more
Despite increasingly aggressive rhetoric from the agencies, 2022 was largely characterized as “business as usual” in the antitrust world. In contrast, 2023 featured a significant step up in enforcement activity, including...more
ACI’s FDA Boot Camp – now in its 42nd iteration – continues to provide the working knowledge of core essentials of FDA law and regulation, including the new amendments under the Food and Drug Omnibus Reform Act (FDORA). This...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
ACI’s FDA Boot Camp is back in Boston! This essential training course – now in its 41st iteration – continues to provide the working knowledge of core essentials of FDA law and regulation, including the new amendments under...more
The wait is finally over. On June 7, 2023, after remaining silent for over an entire year, the US Food and Drug Administration (“FDA”) Office of Prescription Drug Promotion (“OPDP”) issued its first untitled letter of 2023 to...more
After two years of decreased enforcement activity (with an out-sized portion of activity being COVID-19-related), the Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) has issued several Untitled...more
On March 11, 2022, the United States Court of Appeals for the Second Circuit affirmed the dismissal of claims under Sections 10(b), 20(a), and 20A of the Securities Exchange Act of 1934 (“Exchange Act”) against a...more
STATISTICAL TRENDS IN FALSE CLAIMS ACT LITIGATION - FCA case activity for 2021 reveals seemingly contrary trends. For the federal fiscal year (FY) that ended September 30, 2021, the DOJ annual report on FCA enforcement...more
FDLI hosted a virtual conference December 9–10, 2021. The keynote address was given by Arun Rao, Deputy Assistant Attorney General at the United States Department of Justice (DOJ). Arun Rao discussed the efforts of the...more
On April 27, 2021, the U.S. Food and Drug Administration (FDA) sent a notice of noncompliance to Acceleron Pharma (Acceleron), accusing the company of failing to post clinical trial summary results on its cancer combination...more
FDA recently issued its first clinicaltrials.gov notice of noncompliance to a clinical trial sponsor for failure to submit clinical trial results to the National Institutes of Health (NIH) databank. ...more
On April 28, 2021, the US Food and Drug Administration (FDA) issued the first-ever Notice of Noncompliance after the drug maker did not comply with its legal reporting obligations for clinical trials upon earlier receipt of a...more
On April 27, 2021, the U.S. Food and Drug Administration (FDA) issued its first Notice of Noncompliance to a company for failing to submit required clinical trial summary results information to ClinicalTrials.gov. In...more
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
As disruption from the COVID-19 pandemic continues, pharmaceutical and medical device companies have been working hard to keep FDA-regulated clinical trials on track. Everyone involved in clinical trials should be acutely...more
On October 1, 2019, the Delaware Court of Chancery issued its decision in In re Clovis Oncology, Inc. Derivative Litigation, C.A. No. 2017-0222-JRS (Del. Ch. Oct. 1, 2019), which addresses the duties of directors to oversee...more