Can Food Really Be Medicine? Transforming Health Care One Bite at a Time – Diagnosing Health Care Video Podcast
Federal Court Strikes Down FDA Rule on LDTs - Thought Leaders in Health Law®
Podcast - Hot Topics in FDA Regulation: GLP-1s, LDTs, AI and More
Prescribing GLP-1 Medications: Be Aware of Legal Limitations
AGG Talks: Cross-Border Business Podcast - Episode 22: What Global Companies Need to Know About Navigating FDA Regulations and U.S. Market Entry
AI and Pharmacovigilance Under the FDA's New Emerging Drug Safety Technology Program – The Good Bot Podcast
GLP-1 Drugs and Cultivated Meat: What’s the Impact on the Food and Agriculture Industry?
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 202: Life Sciences Startups and Industry Developments with Gil Price, Life Sciences Leader
The Future of Laboratory Testing Just Got a Little Clearer: FDA's Final Rule on LDTs – Diagnosing Health Care
Video: Food for Thought and Thoughts on Food: Innovating USDA Science with Sanah Baig, Deputy Under Secretary for Research, Education, and Economics
The FDA's Response to AI Medical Innovation — The Good Bot Podcast
FDA Releases Laboratory-Developed Tests Final Rule – Thought Leaders in Health Law
Litigating Nutrition: Class Action Battles Over Dietary Supplements – Speaking of Litigation Video Podcast
Changes in FDA, Cannabis Policies and AI Developments
Ad Law Tool Kit Show – Episode 2 – Marketing FDA-Regulated Products
Medical Device Legal News with Sam Bernstein: Episode 18
Medical Device Legal News with Sam Bernstein: Episode 17
A Look Into the FDA and USDA Regulatory Regimes
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 167: Dr. Ehsan Samei & Dr. Susan Halabi, Triangle CERSI
Byonyks, a medical device company focused on advancing dialysis care, today announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the Byonyks X1 APD Cycler, an automated peritoneal...more
Recent activity among lawmakers and federal agencies signal that the government may be poised to undertake meaningful legislative and administrative efforts to harness the potential of digital health innovation and to expand...more
News Briefs - States, D.C., File Lawsuit to Block Trump's HHS Restructuring - A coalition of 20 attorneys general is suing to block what they say is the Trump administration's "dangerous dismantling" of the federal health...more
U.S. Senate Artificial Intelligence Caucus co-chairs Mike Rounds (R-SD) and Martin Heinrich (D-NM) recently introduced S. 1399, the “Health Tech Investment Act,” which would establish a Medicare reimbursement pathway for...more
With daily media reports citing to the explosion of interest in Artificial Intelligence (“AI”), AI start-ups have attracted a huge capital influx. During the last fiscal quarter of 2024 ending on December 31st, investors...more
As the New Year begins, questions surrounding how recent election results will impact technology regulation across industries loom large. It’s hardly a bold prediction that artificial intelligence (“AI”) and the regulation...more
On October 30, 2023, President Biden signed Executive Order 14110, laying the groundwork for the ethical and secure deployment of AI across industries, including healthcare. This comprehensive directive outlines policy goals...more
News Briefs - Congress Taking on Healthcare Policies Set to Expire - Congress has begun discussions on important healthcare policies set to expire on December 31....more
AdvaMed, the world’s largest medical technology association representing device, diagnostics and digital technology companies, released a white paper that reviews the current landscape of artificial intelligence (AI)-based...more
Healthcare in the United States is undergoing significant changes, particularly in the areas of reimbursement and coverage of telehealth, substance use disorders (SUDs), and mental health services. The proposed 2025 Physician...more
The U.S. Food and Drug Administration's ("FDA") new advisory committee on digital health is set to examine its approach for evaluating and regulating the safety and effectiveness of medical devices utilizing generative...more
News Briefs - FTC Finalizes Providers' Reporting Rules Prior to M&A - The Federal Trade Commission finalized changes to a rule that will require healthcare companies, including hospitals and providers, to provide more...more
On August 7, 2024, the Centers for Medicare & Medicaid Services (“CMS” or the “Agency”) issued a final procedural notice (“Notice”) outlining a new Medicare coverage pathway, aimed at achieving timelier and predictable access...more
On August 1, 2024, the U.S. Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) issued an untitled letter to Mirati Therapeutics Inc., a Bristol Myers Squibb Co. (Mirati), relating to promotional...more
Heather and Matthew welcome Dr. Gil Price, who has had an impressive career in the life sciences industry as a recently retired executive and currently serves as a board member for numerous companies. As an experienced leader...more
Antibody-drug conjugates (ADCs) are a promising class of cancer treatments with an accelerating number of U.S. Food and Drug Administration (FDA) approvals and rapidly growing market size, as discussed in previous articles in...more
...It takes a lot to bring a medical product to market in the United States. You need impactful technology and proper resources to develop a product for years without the assurance it will ever see a patient. Understanding...more
Wilson Sonsini’s 31st Annual Medical Device & Digital Health Conference will address topics of critical importance to medical device and digital health companies, including early and late-stage venture financing, partnering...more
For music aficionados, many would agree that the rock band, Pink Floyd, was ahead of its time. “Welcome to the Machine,” from the 1975 album Wish You Were Here, was one of those transformative songs for one of this Bulletin’s...more
Join Gardner Law for a half-day CLE event in person at the Capital Factory in Austin, TX or attend virtually. Prepare for the regulatory rodeo with confidence by learning how to navigate regulatory, compliance, and privacy...more
On March 5, 2024, the US Food and Drug Administration (FDA) granted clearance to market the first over-the-counter (OTC) continuous glucose monitor (CGM). Dexcom’s Stelo Glucose Biosensor System (Stelo) is an integrated CGM...more
We have been writing about software as a medical device (SaMD) for years, tracking the Food and Drug Administration's (FDA) efforts to keep up with the fast-paced development of digital technology, such as launching the...more
The American Conference Institute hosted its inaugural Life Sciences AI Summit in New York on February 21 and 22. The two-day conference brought together key stakeholders, including regulatory players such as FDA and the...more
On December 13, 2023, the U.S. Department of Health and Human Services (HHS) Office of the National Coordinator for Health Information Technology (ONC) published a wide-ranging final rule, Health Data, Technology, and...more
Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more