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
HHS Policy Changes, Supreme Court Rulings, and the DOJ-HHS False Claims Act Working Group
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 246: The Next Generation of Treatment for Alzheimer's and Parkinson’s with Neal Goodwin and Pawel Krysiak of Jaya Bio
AI Today in 5: August 11, 2025, The ACHILLES Project Episode
False Claims Act Insights - Bitter Pills: DOJ Targets Pharmacies for FCA Enforcement
Key Discovery Points: BYOD Case Law Covering Subpoenas and Employee Handbooks
Daily Compliance News: June 23, 2025, The Is Walmart Cool Edition
Taking the Pulse: A Health Care & Life Sciences Video Podcast | Episode 239: Understanding the 340B Pricing Program with Chuck Melendi of Disruptive Dialogue
Unexpected Paths to IP Law with Dan Young and Colin White
Navigating Legal Strategies for Covering GLP-1s in Self-Insured Medical Plans — Employee Benefits and Executive Compensation Podcast
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
AGG Talks: Cross-Border Business Podcast - Episode 28: How Life Sciences Companies Can Create a Culture of Compliance When Expanding to the U.S. Market
How Life Sciences Companies Can Create a Culture of Compliance When Expanding to the U.S. Market
Podcast - Hot Topics in FDA Regulation: GLP-1s, LDTs, AI and More
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 231: Advancing the Life Sciences Industry with Kendalle O’Connell of MassBio
Compliance Program Effectiveness: Keep it Streamlined and Strategic
AGG Talks: Cross-Border Business Podcast - Episode 26: U.S. Enforcement Trends Targeting Foreign Pharmaceutical and Medical Device Manufacturers
Podcast — Drug Pricing: 2025 J.P. Morgan Healthcare Conference Takeaways and Outlook
Prescribing GLP-1 Medications: Be Aware of Legal Limitations
Podcast — The Growth Rocketship: How BridgeBio’s Hub and Spoke Portfolio Strategy Set the Market for the Future of Biotech — Then, Now, and What’s Next?
The Food and Drug Administration (FDA) issued final guidance Monday that explains how medical device manufacturers can use a Predetermined Change Control Plan (PCCP) to update AI-enabled device software functions (AI-DSFs)...more
The FDA began integration of generative AI across all its centers, a project that should be completed by the end of June. Newly appointed chief AI officer, Jeremy Walsh, and Office of Strategic Programs at CDER, Sridhar...more
Welcome to Vital Signs, a curated compilation of the latest legal and regulatory developments in digital health....more
The U.S. Food and Drug Administration (FDA) has been ahead of the curve for a number of years on emerging issues and opportunities for the agency and regulated industry arising from the advent and evolution of artificial...more
To help you stay on top of the latest news, our AI practice group has compiled a roundup of the developments we are following....more
In 2024, not one but two Nobel Prizes (in Chemistry and Physics) were awarded to researchers for their work in artificial intelligence ("AI"). Particularly noteworthy for the life science community is the Nobel Prize in...more
Early in the new year, the US Food and Drug Administration (FDA) released two anticipated draft guidance documents focused on artificial intelligence (AI): Artificial Intelligence-Enabled Device Software Functions: Lifecycle...more
In January, the U.S. Food and Drug Administration (FDA) issued its first guidance on the use of artificial intelligence (AI) models in drug development and in regulatory submissions titled, “Considerations for the Use of...more
Artificial intelligence already is positively affecting health, according to Mark Gardner, MBA, Esq., Founder and Managing Partner, Gardner Law, which represents clients subject to Food and Drug Administration regulations....more
Every year, 12,000 leaders in the healthcare industry meet at HLTH. This year's conference covered all aspects of the healthcare ecosystem, and here are the nine that we should watch as we enter the new year....more
The US Food and Drug Administration (FDA) recently issued its draft guidance, Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products, on January 6, 2025. ...more
It should come as no surprise that venture capital (VC) investors are drilling down into startups building businesses with Artificial Intelligence (AI) at the core. New data from PitchBook actually shows that AI startups make...more
While generative artificial intelligence ("GenAI") has the potential to fundamentally change health care, it presents unique risks and complexities that challenge the U.S. Food and Drug Administration's ("FDA" or "Agency")...more
As a streamlined method for obtaining U.S. Food and Drug Administration ("FDA") authorization of post-market functionality, FDA issued final guidance recommending the information to include in a Predetermined Change Control...more
118th Congress Continues to Grapple with Contentious CR. With the collapse of Republican support for the negotiated continuing resolution (CR) package, as of the time of publication on Friday at 3:00 PM EST, Congress is still...more
Congress Negotiates Healthcare Extenders, Continues to Plan for 2025. Lawmakers continue negotiations to wrap up the 118th Congress and pass remaining must-do policies, including government funding, likely through a...more
For decades, FDA’s Center for Devices and Radiological Health (CDRH) has been recognizing standards that can be referenced in premarket medical device submissions....more
Welcome to our sixth issue of The Health Record - our healthcare law insights e-newsletter. In this edition, we take a look at the impact of AI when it comes to diverse health data, the FDA and AI medical devices, Virginia's...more
I may be jumping the gun here, but I’m anxious to understand how the new flurry of AI medical devices is performing in the marketplace, or more specifically, whether the devices are failing to perform in a way that...more
In 2024, the landscape of state attorneys general (AGs) is poised for significant change, with numerous elections and regulatory actions reshaping priorities and enforcement strategies. This dynamic environment reflects the...more
The food, drug and medical device industries comprise some of the most closely regulated sectors in the United States. The US Food & Drug Administration (FDA) actively exercises authority by constantly changing legislation...more
n March 15, the U.S. Food and Drug Administration (FDA) published a paper titled “Artificial Intelligence and Medical Products: How CBER, CDER, CDRH, and OCP are Working Together.” This paper describes the FDA’s strategy for...more
Both the EU and Germany are taking significant steps to accelerate digitalization in the health sector and facilitate the exchange and use of health data for research and innovation purposes. They aim to improve...more
Artificial intelligence or AI isn’t going anywhere, and the FDA is the latest agency to recognize its potential to revolutionize healthcare by advancing medical product development, improving patient care, and expanding the...more
Artificial Intelligence (AI) has emerged as a major player in the realm of health care, promising to completely transform its delivery. With AI’s remarkable ability to analyze data, learn, solve problems, and make decisions,...more