Top 5 Life Sciences Regulatory & Policy Updates
This newsletter summarizes the top five recent regulatory updates and policy changes impacting the U.S. life sciences and healthcare industries. 1. New State Laws Create a Patchwork of AI Regulation in Healthcare While U.S. Congress failed to pass a federal moratorium on Artificial Intelligence (AI) legislation, states are aggressively moving forward with new regulatory regimes, […]
Why Your PI Agreement Might Be a Ticking Time Bomb
When was the last time you read your Principal Investigator’s agreement cover to cover? For many clinical trial sites, the physician employment contract feels like a box-checking exercise. Draft it, sign it, file it away, and move on. But here’s the uncomfortable truth: These agreements are the foundation of your research program and the wrong […]
When Patient Assistance Becomes a Legal Minefield
For two decades, OIG guidance has warned that manufacturer-run Patient Assistance Programs are high-risk under the Anti-Kickback Statute. Directly covering Medicare co-pays for your own drug? Red flag. Funding a “charity” that only helps patients on your product? Still risky. The 2005 OIG Special Advisory Bulletin outlined safe harbors—donate only to truly independent charities, keep […]
Dan Sfera and Darshan Kulkarni Discuss Clinical Trial Advertising and Patient Advocacy
In this insightful discussion, Dan Sfera and Darshan Kulkarni explore how clinical trial advertising is evolving in today’s highly regulated environment. They share perspectives on balancing outreach with compliance, highlight the critical role of patient advocacy in building trust, and discuss strategies to ensure ethical and effective communication with diverse patient populations. Together, they examine […]
FDA Guidance on Digital Health Technologies
What healthcare companies need to know—straight from a legal lens.Digital health is no longer the future—it’s the present. From wearable sensors to software that supports clinical trials, Digital Health Technologies (DHTs) are transforming how healthcare is delivered and regulated. The FDA’s latest guidance aims to bring clarity, but for many businesses, it also raises new […]
Upcoming FDA Guidelines Webinar
At Kulkarni Law Firm, we take pride in being recognized by leading industry bodies, legal publications, and healthcare organizations for our expertise in FDA law, healthcare compliance, and digital health innovation. These accolades reflect our commitment to delivering strategic, client-focused legal solutions that stand up to the highest standards.
Recognized for Excellence in Regulatory Law
At Kulkarni Law Firm, we take pride in being recognized by leading industry bodies, legal publications, and healthcare organizations for our expertise in FDA law, healthcare compliance, and digital health innovation. These accolades reflect our commitment to delivering strategic, client-focused legal solutions that stand up to the highest standards.Our recognitions underscore one thing: trusted legal […]
SOPs: How Many is Too Many?
Follow DarshanTalks for more insights on regulatory trends, practical legal advice, and candid conversations from the front lines of FDA law. Available on Spotify and other major platforms.
FDA Guidance on Digital Health Technologies
Understanding FDA Guidance on Digital Health Technologies What healthcare companies need to know—straight from a legal lens.Digital health is no longer the future—it’s the present. From wearable sensors to software that supports clinical trials, Digital Health Technologies (DHTs) are transforming how healthcare is delivered and regulated. The FDA’s latest guidance aims to bring clarity, but […]
How project management is a game changer in clinical research
Jessica Thompson discusses how project management can be a game-changer in clinical research. We talk about how poor project management can lead to delays, cost overruns, and regulatory violations, and that lawyers can play a role in ensuring that clinical research projects are managed effectively. Thompson emphasized the need for early planning and communication between […]
