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
On July 30, 2025, the U.S. Department of Justice (DOJ) announced that biotechnology company Illumina Inc. agreed to pay $9.8 million plus interest to resolve allegations of misrepresenting compliance with federal...more
Neil Young once sang of adapting to a world ruled by data and digital minds in “Computer Age.” Today, that vision feels increasingly real as the Food and Drug Administration turns to artificial intelligence (“AI”) in the face...more
Since the previous quarter’s Life Sciences Snapshot, robust dealmaking activity in Q3 has launched YTD life sciences VC deal activity to near parity with 2023 figures, firmly positioning 2024 as the year to break the two-year...more
In September 2024, the U.S. Food and Drug Administration (FDA) issued three guidance documents to support different clinical trial approaches, including trials that implement decentralized elements, trials that allow...more
Our Food & Beverage and FDA teams explore a plan from a trio of federal agencies that seeks to implement regulatory reform and update the Coordinated Framework for the Regulation of Biotechnology....more
Press releases report that Boston Scientific (BSX) has entered an agreement to acquire medical device developer Silk Road Medical in a deal totaling $1.16 billion. Silk Road Medical has reportedly developed devices and...more
As we recently discussed, the Federal Trade Commission (“FTC”) sent warning letters to certain drug manufacturers regarding their purportedly improper listing of device patents in the Food and Drug Administration’s (“FDA”)...more
FDA law firm Gardner Law and EU-based Fieldfisher discuss regulatory, compliance, and privacy matters relevant to high-tech healthcare products. - - Harnessing AI and Connected Devices in Medical Innovation in an...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
Products incorporating artificial intelligence/machine learning (AI/ML) algorithms have enormous potential for health care. The power of AI can enhance the capabilities of software that has the potential to benefit more...more
Artificial Intelligence (AI) has long been associated with science fiction movies about dystopian futures, leading to fear among the general public about its potential impact. This is especially the case today for those in...more
Wilson Sonsini is pleased to present the latest edition of The Life Sciences Report. This issue features an article on interlocking boards in the life sciences sector and the antitrust risk they pose to firms and investors;...more
Last week, Diana DeGette (D-CO) and Fred Upton (R-MI) introduced in the House highly anticipated bill language for “Cures 2.0”, a follow-up to the transformational 21st Century Cures Act enacted in 2016... The 21st Century...more
The premier event for drug and medical device product liability lawyers to gain essential winning litigation strategies. ACI’s 26th Annual Flagship Conference on Drug and Medical Device Litigation is returning to New York...more
On August 9, the U.S. Food and Drug Administration (FDA) published a notice announcing its implementation of the U.S. Court of Appeals for the D.C. Circuit’s April 2021 decision in Genus Medical Technologies LLC v. U.S. Food...more
The U.S. Court of Appeals for the D.C. Circuit recently decided in Genus Medical Technologies LLC v. U.S. Food and Drug Administration that, when classifying a biomedical product as either a “drug” or a “device,” FDA does not...more
On September 23, the U.S. Food and Drug Administration (FDA) published a proposed rule to modify its intended use regulations to clarify the types of evidence FDA will consider when determining the “intended use” of a medical...more
On June 10, 2020, the Ninth Circuit affirmed the dismissal of a putative securities fraud class action in a potentially significant decision for securities defendants, particularly those in the pharmaceutical, biotech and...more
For-cause inspections will proceed if deemed “mission critical.” The US Food and Drug Administration (FDA) had previously announced on March 10 that routine foreign inspections were suspended. FDA suggests that it may attempt...more
The World Health Organization (WHO) has determined that the 2019 novel coronavirus is a “global pandemic” and President Trump has declared a national emergency as the impact of the virus on all aspects of daily life continues...more
We are pleased to provide you with the third annual installment of our Life Sciences and Health Care Horizons guide. For each of these guides, we have asked our industry thought leaders throughout the world to write about...more
Food/Dietary Supplements - Court Enters Consent Decree Against Food Facility – A Michigan-based food manufacturer will “discontinue selling food products until the company complies with federal regulations and other...more
Medical device and diagnostics companies and laboratories should anticipate significant legal, regulatory and market changes in 2020 that will have a lasting impact on the industry. From revisions to how the government...more
Actionable Strategies for Drug and Medical Device Products Liability Litigators and In-house Counsel - ACI’s Drug and Medical Device Litigation conference is the only event which brings together an exceptional in-house...more
Navigating the U.S. Healthcare Regulatory Landscape for Wearable Devices - Complex Environment Includes Key Federal Agencies FDA, FTC, OCR, CPSC, CMS, and OIG - The wearable device market is emerging as a key player...more