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PODCAST

DarshanTalks Podcast

Darshan Kulkarni

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

science life sciences

All Episodes

7:00

Who Owns AI Generated Content in Pharma?

DarshanTalks Podcast ·

2024/06/08

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, the New York Times' lawsuit against OpenAI, highlighting the contentious issue of data ownership. As pharma companies increasingly rely on AI for content generation, they must navigate murky waters to ensure compliance with existing regulations and respect for intellectual property rights.Controllin...

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0:48

Legal Minute: Why does my drug cost so much?

DarshanTalks Podcast ·

2024/06/07

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 $630,000 daily during this process. Imagine going to a casino every day, betting that much money without knowing the outcome, for 10 to 15 years. What kind of return would you expect on that investment? That's why drugs are so expensive.Support the Show.

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0:57

AI for Promotions in FDA-Regulated Industries

DarshanTalks Podcast ·

2024/06/06

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 into AI's role in promotional and non-promotional communications within the pharmaceutical and medical device industries. From regulatory compliance and ethical considerations to the latest FDA guidance, we'll cover it all. Whether you're a legal professional, an industry insider, or simp...

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0:44

Legal Minute: Billion-Dollar Speaker Scheme!

DarshanTalks Podcast ·

2024/06/05

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, device product, or disease state on behalf of the sponsoring company. Typically, the company compensates the speaker with an honorarium and may also provide remuneration, such as free meals, to attendees. Between 2017 and 2020, drug and device companies reportedly paid nearly $2 billion to HCPs f...

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24:35

Off-Label Risks: Compliance Matters Now More Than Ever

DarshanTalks Podcast ·

2024/06/03

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? Lessons from the US v. Eli Lilly 2009 case How do recent court decisions impact off-label promotion? United States v. Caronia and US v. Facteau How are weight loss drugs, initially approved for treating diabetes, reimbursed within Medicare and Medicaid? How are compounded drugs ...

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1:31

6 Must-Knows Before Buying a Drug or Device Company

DarshanTalks Podcast ·

2024/05/30

Buying a Drug or Device Company? 6 Compliance Must-KnowsThinking of acquiring a drug or device company? Buckle up! This deal requires serious compliance considerations. Here's a quick rundown:The DOJ offers a 6-month "safe harbor" for confessing past compliance issues. Use it!The DOJ demands strong compliance programs with thorough risk assessments, effective training, and clear reporting channels.Companies can now claw back bonuses from employees who break compliance rules.Accurate risk asse...

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0:50

Are there chemo drug shortages?

DarshanTalks Podcast ·

2024/05/28

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, shortages still exist for some drugs. Staying informed is crucial, and the FDA is actively tracking drug shortages to mitigate them. It's important to communicate with your doctor, who can provide the latest information and discuss alternative treatment options tailored to your needs.

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0:35

Legal Minute: Don’t Ignore State Registrations

DarshanTalks Podcast ·

2024/05/24

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 include1. Hefty fines, revoked licenses, and even legal charges, potentially ruining your business. 2. Additionally, non-compliance can result in reputational damage, eroding public trust and deterring potential partners. 3. Moreover, loss of distribution rights could leave you unable to serve customers in entire states...

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0:59

Legal Minute: 6 Crucial Mistakes in Informed Consent

DarshanTalks Podcast ·

2024/05/20

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: Staff members did not take the time to thoroughly discuss the study's potential benefits and risks with prospective subjects.3. Inadequate Training: Coordinators lacked knowledge about the study and lacked a research background, leading to insufficient information provided to participants.4. Unauthor...

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0:46

Legal Minute: What is informed consent in clinical...

DarshanTalks Podcast ·

2024/05/16

Informed consent is a crucial aspect of clinical trials, ensuring that prospective subjects understand the benefits, risks, and potential harms of participating in a study. This process involves full disclosure of information, allowing subjects to ask questions and address concerns with a knowledgeable medical professional. For minors, parental involvement is required, and subjects have the right to withdraw consent at any time. It's not merely a form but an ongoing process that starts b...

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22:53

Stop Risky Ads: Class Actions Could Cost You

DarshanTalks Podcast ·

2024/05/13

In this podcast, we discuss the following: Recent updates from the courts in class action lawsuits. Difference between equity and law. Demerging or diverging equity and law. Dictionaries used by courts to interpret contracts. Update on Johnson and Johnson baby powder case (Suing plaintiff’s witnesses for defamation and false advertising) Experts need to be cautious to avoid false advertising allegations against them. Update on Maybelline 24-hour make-up case...

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0:14

Legal Minute: How do drugs work?

DarshanTalks Podcast ·

2024/05/08

Darshan explains that drugs work by either enhancing or inhibiting processes that already occur in the body. Put simply, they amplify or reduce the body's natural functions. This fundamental principle underscores how drugs interact with our biology.

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0:56

Legal Minute: Don’t Ignore State Registrations

DarshanTalks Podcast ·

2024/04/23

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0:39

Legal Minute: 3 Steps to Avoid Food Recalls

DarshanTalks Podcast ·

2024/04/15

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0:44

Legal Minute: Are dietary supplements as good as drugs?

DarshanTalks Podcast ·

2024/04/12

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0:51

Legal Minute: Clinical Trial Record Retention Disasters

DarshanTalks Podcast ·

2024/04/08

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0:58

Legal Minute: 3 must-do takeaways for collecting...

DarshanTalks Podcast ·

2024/03/29

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0:54

Legal Minute: Are Brand and Generic Drugs Truly...

DarshanTalks Podcast ·

2024/03/23

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0:56

Legal Minute: Who's REALLY Responsible for a Clinical...

DarshanTalks Podcast ·

2024/03/18

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2:53

This Drug Ad is FULL of Red Flags (We Expose Them All!)

DarshanTalks Podcast ·

2024/03/13

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331 results

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