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.
- Update frequency
- every 2 days
- Average duration
- 5 minutes
- Episodes
- 267
- Years Active
- 2023 - 2025
5 reasons not to use AI in creating pharma marketing content
We discuss the risks associated with using AI in your pharma marketing plans:
1. Data Privacy and Security: Ensuring the security and privacy of data, whether it pertains to patients or non-patie…
8 essential elements of a valid prescription
In this episode, we discussed eight essential strategies to prevent prescription drug fraud and abuse:
- Verify the prescriber's identity.
- Know the prescriber's DEA number.
- Know your patient thoroughly.
- Ve…
No more lawyers in PRC?
In this episode we're joined by Heather McFalls, Director of Promotion Compliance at Otsuka Pharmaceutical Companies to discuss the evolving role of ad promo executives and the regulatory landscape i…
Legal Minute: 4 Ways to Get Unapproved Drugs Legally!
Today, we discuss four legal pathways to acquire unapproved drugs.
First, over-the-counter drugs offer a route as some bypass FDA approvals, relying instead on a nomograph.
Second, compounded drugs c…
The 4 Building Blocks of Using AI in any Pharma Marketing Strategy
We discuss the essential elements to ensure that your pharma marketing plan aligns with AI use:
1. Define Clear Goals: Establishing clear objectives is crucial for developing a comprehensive complianc…
Legal Minute: Why Clinical Trials Are Right for You!
In this short, we explore four key reasons to get involved in clinical research.
First, it offers potential access to cutting-edge therapies, though it's important to note you might only receive the s…
Why Clinical Researchers Are Flocking to MedSpas
In today’s episode, our guest is Andrew Stein, a partner in the healthcare department at Stevens and Lee .
Darshan and Andrew discuss MedSpas. MedSpas combine beauty treatments with medical procedures…
Legal Minute: Why You Should Never Trust a Celebrity with Your Health
Darshan explains why you shouldn’t Trust Celebrities When Choosing Your Drugs!
Hidden Agendas: They're paid to promote, not give unbiased advice.
Not Medical Experts: Trust your doctor's knowledge, no…
Essential tips for pharmacy shutdowns
Recent pharmacy walkouts and closures at major chains highlight a critical issue: staffing shortages. Independent pharmacies are also at risk.
Here are 5 tips for pharmacy owners and managers to prep…
Why Clinical Researchers Are Flocking to MedSpas
In today’s episode, our guest is Andrew Stein, a partner in the healthcare department at Stevens and Lee.
Darshan and Andrew discuss MedSpas. MedSpas combine beauty treatments with medical procedures,…
Legal Minute: 5 Surprising Benefits of Ozempic!
We dive deep into 5 uses of Ozempic, a drug known for managing diabetes, but with surprising potential beyond! Here are 5 intriguing uses you might not have heard of:
Liver Support: Early research su…
Who Owns AI Generated Content in Pharma?
In today's episode, we discuss AI-generated content in the pharmaceutical industry. AI has revolutionized content creation, but it's not without its legal and ethical dilemmas. Take, for instance, th…
Legal Minute: Why does my drug cost so much?
In today’s short, Darshan discusses why drugs cost so much. It takes around 10 to 15 years and roughly $2.3 billion to bring a drug to market. That means a drug company spends between $420,000 and $6…
AI for Promotions in FDA-Regulated Industries
Join Darshan Kulkarni, a Food and Drug attorney, as he explores the dynamic intersection of artificial intelligence, drug and device promotion, and the law.
In this podcast series, we'll dive deep i…
Legal Minute: Billion-Dollar Speaker Scheme!
Speaker programs are events sponsored by drug and device companies where a physician or other healthcare professional (HCP) delivers a speech or presentation to fellow HCPs regarding a specific drug,…
Off-Label Risks: Compliance Matters Now More Than Ever
We shed light on the complexities surrounding off-label promotion and reimbursement in the pharmaceutical industry.
We discuss the following:
- What does off-label mean from a reimbursement standpoint?
- L…
6 Must-Knows Before Buying a Drug or Device Company
Buying a Drug or Device Company? 6 Compliance Must-Knows
Thinking of acquiring a drug or device company? Buckle up! This deal requires serious compliance considerations. Here's a quick rundown:
The DOJ…
Legal Minute: Are there chemo drug shortages?
We discuss how recent shortages of chemotherapy drugs like cisplatin and carboplatin have caused delays and changes in treatment plans for some cancer patients. While the situation is improving, shor…
Legal Minute: Don’t Ignore State Registrations
We discuss how failure to register with the appropriate state boards of Pharmacy as a drug or device manufacturer can lead to severe consequences. These consequences include
1. Hefty fines, revoked li…
Legal Minute: 6 Crucial Mistakes in Informed Consent
We discuss six critical errors in the informed consent process:
1. Exclusion of Principal Investigator: PI was not allowed to engage in the informed consent process.
2. Lack of Detailed Discussion: Sta…