Paddle's Payment Predicament: Unpacking FTC's Compliance Crackdown — Payments Pros – The Payments Law Podcast
AI Today in 5: August 22, 2025, The Angst Episode
The Privacy Insider Podcast Episode 17: Security, Cyber-Intel, and a Sense of Humor with Nir Rothenberg of Rapyd
Daily Compliance News: August 22, 2025, The WADA Returns Edition
Regulatory Ramblings: Episode 76 - The Digital Future: The US GENIUS Act and Hong Kong Stablecoins Ordinance / The Hong Kong Web3 Blueprint: Building a Web 3 International Financial Hub Report
Point-of-Sale Finance Series: Understanding the Development and Regulation of Buy Now, Pay Later Products — The Consumer Finance Podcast
Understanding BBB Ratings: Strategic Approaches to Consumer Complaints — Regulatory Oversight Podcast
Compliance Tip of the Day: Co-Thinking with AI
Joint Venture Eligibility Refresher on Requirements for Government Contractors
Compliance into the Weeds: Two Cyber Security Cases for the Compliance Professional
The Road to Regulation: Vehicle Service Contracts Explained — Moving the Metal: The Auto Finance Podcast
AI Today in 5: August 12, 2025, The Creating Billionaires Episode
Compliance Tip of the Day - The ROI of Compliance
AI Today in 5: August 11, 2025, The ACHILLES Project Episode
Taxing Intelligence: AI's Role in Modern Tax Administration
Podcast - An Overview of State Attorney General Consumer Protection Enforcement
LathamTECH in Focus: Move Fast, Stay Compliant
Work This Way: A Labor & Employment Law Podcast | Compliance Clarity for Federal Contractors with Joan Moore and Mim Munzel of Arbor Consulting Group
AI Today in 5: August 6, 2025, The Rethinking Compliance Episode
Compliance Tip of the Day: M&A Domestic Issues
The Trump administration is considering changing the U.S. patent maintenance fee structure from the existing three fixed flat fees to an annual, value‑based “tax” model where patent holders would pay 1%–5% of the estimated...more
The U.S. Food and Drug Administration (FDA) announced a new process called “Rare Disease Evidence Principles” (RDEP), under which eligible drugs and biologics for ultra-rare diseases caused by known genetic defects will...more
The U.S. Food and Drug Administration (FDA) is now releasing complete response letters (CRLs) for BLA and NDA products not yet approved – including CRLs associated with pending or withdrawn applications. ...more
Gardner Law is excited to announce Navigating What's Next: AI, Compliance, and Regulation in Life Sciences, being held live at the Shashi Hotel in the heart of Silicon Valley on November 6, starting at 9:00 a.m. Pacific Time....more
A $9.8 million False Claims Act (FCA) settlement between Illumina Inc. and the U.S. Department of Justice (DOJ) is unique among cybersecurity enforcement actions because it didn’t result from a data breach, but, according to...more
On July 10, 2025, the U.S. Food and Drug Administration (FDA) announced that it was embracing “radical transparency” by publishing more than 200 Complete Response Letters (CRLs) — letters the agency issues to a sponsor when...more
In 2025, Life Sciences and Health Care (LS&HC) companies face rapidly evolving regulatory paradigms that create transactional risks and require daily monitoring. After more than 70 national elections in 2024, the dust hasn’t...more
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
In part three of our three-part webinar series on Risk Management for Your Life Sciences Company, we focus on insurance for foreign clinical trials and provide updates on the clinical trial requirements of various countries....more
The United States Department of Justice (DOJ) recently announced another settlement agreement showing that DOJ continues to prioritize cybersecurity enforcement under the False Claims Act (FCA). According to the press...more
A new law in Florida, CS/CS/SB 1768, allows physicians to market and administer stem cell therapies that have not been approved by the U.S. Food and Drug Administration (FDA) for orthopedic conditions, wound care and pain...more
At both the federal and state levels, 2025 has seen new developments for cell-cultured meat. Here we provide an overview of cell-cultured meat (also known as cultivated meat) and these recent regulatory developments....more
Question: How does Montana’s amendment to its Genetic Information Privacy Act (“GIPA”) regulate neurotechnology data, and what obligations might my business face compared to the amendments that were passed in Colorado and...more
Agendia made two posts on LinkedIn that linked to articles in which Dr. Nathalie Johnson touts Agendia’s genomic test to evaluate early-stage breast cancer over Genomic Health’s competing test. Genomic Health filed an NAD...more
Life sciences companies racing to harness artificial intelligence often stumble into preventable traps that can derail innovation and create lasting legal exposure. ...more
The US Food and Drug Administration (FDA) recently announced the availability of the first-ever centralized database of Complete Response Letters (CRLs) on openFDA, one of several steps taken under the agency’s initiatives to...more
On July 31, the U.S. Department of Justice (DOJ) announced a settlement in United States ex rel. Lenore v. Illumina, Inc, the first case in which underlying cybersecurity issues formed the basis of a settlement under the...more
On August 6, 2025, the U.S. Food and Drug Administration (FDA) became the latest governmental agency to confirm that fluoropolymers are both safe and necessary. After an independent safety review of fluoropolymers in medical...more
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published its responses to the consultation on Medical Device Regulations: Routes to market and in vitro diagnostic devices carried out last year....more
On this Ropes & Gray podcast, licensing and collaboration partner Hannah England and antitrust partner Lisa Kaltenbrunner discuss how EU antitrust rules impact non-competes and other exclusivity provisions in collaboration...more
Through our Venable FDA Pulse series, we report on critical developments within the Food and Drug Administration (FDA or Agency) that may affect the Agency's structure and stakeholder interactions....more
Drug and device manufacturers are increasingly targeted by cyber threats that can compromise patient safety, intellectual property, and other critical data and systems, while also facing new regulatory demands. As regulators...more
Life science companies are tapping into artificial intelligence (AI) to improve how they work, transforming the way they handle data and approach product research and development. They’re using AI to speed up key processes...more
The Centers for Medicare & Medicaid Services (“CMS”) recently released two proposed updates to Medicare payment rules that, if implemented, could have a significant impact on life sciences companies. The Medicare proposed...more
Functional foods designed to promote relaxation, better sleep, and improved mood have exploded in popularity, and chocolate is increasingly the delivery method of choice. Calming confections featuring ingredients like...more