DarshanTalks Podcast
Welcome to DarshanTalks!
We demystify fraud for legal, regulatory, and compliance essentials in the life sciences and pharmacy industries. Through engaging 15-30-minute interviews with influential change makers, short educational regulatory defbriefs, and 60 second audio takeaways, we unveil the strategies behind bringing drugs and devices to market—and keeping them there!
Powered By The Kulkarni Law Firm - Helping regulators see your business the way you do.
We focus on life science issues involving medical affairs, marketing and advertising, and clinical research so that you can learn about the industry, enhance your business and grow your career.
DarshanTalks Podcast
The FDA's Crisis Is Now Your Problem
The FDA you designed your protocol around may no longer exist. In this episode, Darshan Kulkarni breaks down why clinical researchers, regulatory attorneys, and promotional review teams need to pay attention—now.
With mass layoffs, frozen guidances, and a reorganization shaking CDER and CBER to their core, trial timelines, IRB reliance, and even legal interpretations are in flux. Marketing teams are flying blind with the FDA’s communications division gutted and post-Loper Bright challenges looming large.
Darshan outlines urgent next steps:
✔️ Rethink your submission timelines
✔️ Reassess your SOPs for oversight and reporting
✔️ Update your promotional risk strategy—especially in digital
If you're in life sciences and relying on yesterday’s FDA to approve tomorrow’s innovation, it’s time to rethink.
Reach out to the Kulkarni Law Firm—we specialize in compliance during regulatory chaos.
