DarshanTalks Podcast @DarshanTalks
#generalcounsel and #regulatory guy working on #clinicaltrials, #marketing and #medicalaffairs in the #LifeSciences 🌈 darshantalks.com Philadelphia, Pa Joined February 2010-
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Should sites know why they weren’t chosen? We explore when sponsor feedback makes sense, the legal and practical risks involved, and how sites can use insights to refine their processes, strengthen relationships, and improve performance for future trials. bit.ly/3VAWxKk
The government is targeting marketing programs. I break down the FTC investigation of Hims & Hers and Texas’ lawsuit against Lilly. Watch the video to learn strategies to stay compliant and protect patient trust. buff.ly/6zZIZN7 #pharmamarketing #digitalhealth #klf
The government is targeting marketing programs. @DarshanTalks breaks down the FTC investigation of Hims & Hers and Texas’ lawsuit against Lilly. Watch the video to learn strategies to stay compliant and protect patient trust. buff.ly/6zZIZN7 #pharmamarketing #klf
A new telehealth model just got the regulatory go-ahead. Find out how management companies can lease providers and offer backend services without violating kickback laws. I cover the safe harbor framework, FMV rules, and key red flags to avoid. Click below. #telehealth #klf
Pharmacy enforcement is heating up! I explain how the Eastern District is using the the False Claims Act to target pharmacies and what steps owners can take to protect themselves. Click below. #pharmacycompliance #falseclaimsact #kulkarnilawfirm #klf
Transferring a medical device? Your checklist better go beyond the obvious. It’s not just about paperwork—it’s about regulatory survival. We’ve flagged 7 essentials that can make or break your transfer. View the infographic before your next move. #medicaldevices #klf
Pharma’s most underrated transformation? It wasn’t a blockbuster drug. It was the journey from Direct-to-Consumer to Direct-to-Patient. 💥 Check out the timeline to understand the how—and what’s next 👇 #directtopatient #DTC #pharmamarketing #kulkarnilawfirm #klf
Your 2025 KOL strategy could backfire—big time. If you’re picking based on name recognition, not trial readiness, you’re inviting scrutiny. Edye and I reveal what regulators really want to see from your expert roster. buff.ly/93nbu9Z #keyopinionleaders #KOLstrategy #klf
The clients we’ve served? They’re not just businesses. They’re research sites, sharp consultants, and determined law firms trying to get it right. Edye and I talk about what it means to grow alongside the people you serve. buff.ly/9d8jxdP #lifescienceclients
The DOJ has a new target: DEI programs.Companies receiving federal funds are now under pressure to prove their diversity efforts comply with Title VI and Title IX. I explore how to safeguard your policies before investigators show up buff.ly/wokidh2 #DOJenforcement #klf
Charitable donations by pharma are under scrutiny. Regulators are cracking down on potential kickbacks. Ensuring compliance isn’t just a legal requirement—it’s a necessity for long-term success. Click below for details! buff.ly/tAhyPav #charityfunding #klf
FMV could be the most misunderstood number in clinical research.We explore how FMV is calculated, who decides the numbers, and why Medicare benchmarks don’t always reflect real-world burdens. Watch to learn what your site or your sponsor might be missing buff.ly/Dlq2efC
Can non-physicians own clinical trial sites? I break down the complex laws surrounding non-physician ownership in clinical research and explains why it’s crucial to understand the legal implications. Watch now! buff.ly/Al4nfwx #clinicalresearch #researchsites #klf
If your platform collects health data, you need to hear this. I discuss the wave of legal challenges facing telehealth companies over privacy breaches, pharma partnerships, and advertising risks. Click here to learn more buff.ly/JxGtH1z #pharmamarketing #telehealth #klf
Should every site get paid the same in a clinical trial? Watch as Edye Edens and I break down how geography, staffing, and patient access impact site value. Learn how real-world costs clash with one-size-fits-all FMV models. Click here buff.ly/8Nsafpg #klf
What does a political healthcare bill have to do with research? More than you’d think. We explain how policy shifts like the Big Beautiful Bill can disrupt clinical trial infrastructure by shrinking site networks and limiting participant coverage.buff.ly/QlFiCMD #klf
Could Your DTP Campaigns Be the Next Legal Target? 🎯 A recent court ruling shows how innocent marketing tactics can snowball into serious legal trouble. Watch now to learn how to stay on the right side of the law 👇 #pharmacompliance #directtopatient #kulkarnilawfirm
s AI really ready to draft your informed consent forms? Edye and I explore how tools like ChatGPT can speed up first drafts—but also raise serious concerns around IRB templates, OHRP compliance, and patient safety. buff.ly/9EakDVQ #informedconsent #AIinpharma #klf
🚨 Novo just pulled the plug on its Hims partnership—just two months in. What happened? I outline the compliance and strategy missteps. Click to read more 👇 #pharmacompliance #telehealthregulations #kulkarnilawfirm #klf
Is Your Pharmacy Ready for the Next Audit? I break down the growing risks pharmacies face when audits strike. Click to learn key strategies and practical tips that will keep your practice compliant, your staff trained, and your license secure. buff.ly/TJVIFW2 #auditrisk

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