DarshanTalks Podcast

Darshan Kulkarni
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  • LIFE SCIENCES
  • UPDATED TWICE WEEKLY
DarshanTalks Podcast 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. 

  1. 2 DAYS AGO

    Why are medicine names so complicated?

    Darshan was asked to explain why drug names can be so complicated, and the answer lies in the fact that each drug typically has at least three distinct names. First, there’s the chemical name, which is a technical identifier describing the drug’s molecular structure—these names are often long and complex, like “acetylsalicylic acid,” and are more for scientific use. Next, there’s the generic name, which is what most people are familiar with, such as “penicillin” or “aspirin.” These names are ...

    2 min

  2. 3 DAYS AGO

    Fixing Congruency Reviews in 8 Minutes

    In this episode, Istvan Fekete joins us to discuss the intricacies of Congruency Reviews. We will explore the common mistakes individuals may encounter during these reviews and examine effective strategies for handling these errors. Additionally, we will delve into the processes that can be implemented to mitigate risks associated with congruency reviews. The discussion will also cover the potential benefits of involving third-party to ensure the accuracy and integrity of the review process.P...

    9 min

  3. 17 SEPT

    The Dark Side of Med Device Kickbacks

    Today, we're discussing a critical issue for pharmaceutical and medical device marketers – promotional compliance.Overview of the Innovasis Settlement:Innovasis Inc. recently settled a $12 million case for alleged kickback schemes to doctors. This highlights the importance of promotional compliance.Allegations Against Innovasis:From Jan. 1, 2014, to Dec. 31, 2022, Innovasis allegedly provided improper remuneration to surgeons, inducing them to use their products. These remunerations included ...

    5 min

  4. 14 SEPT

    Which Hair Loss Treatment Is Right for You?

    Darshan addresses common questions about potential treatments for hair loss. He provides insights based on his expertise as both a pharmacist and an FDA regulatory lawyer.Darshan explains that FDA-approved treatments for hair loss include minoxidil and finasteride. Minoxidil, originally a blood pressure medication, can lower blood pressure and has other side effects. Finasteride, used for benign prostatic hypertrophy, is also FDA-approved for hair loss but has limitations and potential side e...

    2 min

  5. 9 SEPT

    Analyzing the Publication Rights Clause in CTAs

    Today's discussion revolves around the legal clauses found in clinical trials, with a focus on Article 8, the Publication Rights Clause.The following points are discussed:Unrestricted Rights: The clause provides the Site with unrestricted rights to publish all trial data. This is excessive and could jeopardize the Sponsor's control over the integrity and proper use of the data.No Sponsor Review: There's no requirement for the Sponsor to review or approve publications, which can lead to i...

    2 min

  6. 7 SEPT

    What Really Starts Pharmacy Investigations?

    We discuss the seven ways pharmacy investigations can begin:1. Data Analysis: Agencies like the DEA and DOJ monitor prescription data for unusual patterns, such as excessive dispensing of certain drugs.2. Tips: Anonymous reports from the public or industry insiders alert authorities to suspicious activities.3. Whistleblowers: Individuals within organizations can confidentially report wrongdoing, potentially leading to legal action under the False Claims Act.4. Patient Complaints: Concerned pa...

    2 min

  7. 20 AUG

    🔒 Is your clinical trial AI racist?

    Subscriber-only episodeWe dive into the critical issue of racial bias in AI, highlighted by a recent Yale study focusing on ChatGPT. This has significant implications for clinical research sponsors, sites, and principal investigators. We also explore the FDA's perspective on AI in clinical trials, presented by Dr. Elzarrad.Overview of the Yale Study:The Yale study found that ChatGPT demonstrates racial bias in its responses, raising concerns about the use of AI in clinical research. Biased AI...

    5 min

  8. 17 AUG

    Another Pharmacy owner Jailed in Fraud Case

    Today we're diving into a critical issue that has shaken the pharmacy world. Recently, a pharmacy owner was sentenced for paying illegal kickbacks and engaging in a money laundering conspiracy. This case has significant implications for promotional compliance within the pharmacy industry, and we're here to explore them in detail.In a landmark case, the Department of Justice sentenced Richard Hall, a 53-year-old pharmacy owner from Fort Worth, to several years in prison. The charges? Hall paid...

    3 min
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About

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. 

Information

  • Creator
    Darshan Kulkarni
  • Years Active
    2019 - 2024
  • Episodes
    107
  • Rating
    Clean
  • Copyright
    © 2024 DarshanTalks Podcast
  • Show Website
    DarshanTalks Podcast

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