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
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
H. Lee Moffitt Cancer Center & Research Institute Hospital Inc. in Tampa, Florida, has agreed to pay $19.564 million to settle false claims allegations over claims submitted to federal health care programs for items and...more
This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity for December 2023. We discuss several civil and criminal enforcement actions that involve alleged violations of the False...more
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
As we reflect on 2023 and make predictions for 2024, it is remarkable the number of significant events occurring this past year that will be impactful for the activities of the life sciences industry going forward. Although...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
Stay on top of the latest in research compliance - Do you want to learn: - Current best practices for building and maintaining a research compliance work plan? - How to better shift your program’s research focus in...more
In early April, the U.S. Department of Justice (DOJ) Civil Division’s Consumer Protection Branch (CPB) published its first-ever “Recent Highlights” report. The report provides background on the CPB, highlights from its recent...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
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
State AGs in the News- Governor Newsom Nominates Rob Bonta for California Attorney General- •Governor Gavin Newsom nominated California Assemblyman Rob Bonta to replace Xavier Becerra as California AG. Bonta’s...more
Participating in clinical trials can leave health care providers vulnerable to false claims liability if Medicare rules are not closely followed. This publication reviews settlements involving clinical trials, provides an...more
DOJ News - Manufacturer to Pay Over $37.5 Million to Resolve False Claims Act Allegations - On January 15, 2015, the DOJ announced that ResMed Corp., a manufacturer of durable medical equipment, agreed to pay over...more
Practical advice following the Primex Clinical Laboratories settlement - Earlier this year, the Department of Justice (DOJ) announced a $3.5 million settlement against Primex Clinical Laboratories, a California laboratory...more
Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...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
The bill known as the “21st Century Cures,” H.R.6, would extend Civil Monetary Penalties (CMPs) to cover false claims and false statements relating to grants, contracts, and other agreements funded by the Department of Health...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