70 épisodes

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 Darshan Kulkarni

    • Sciences

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. 

    Are there chemo drug shortages?

    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, 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.

    • 50 s
    Legal Minute: Don’t Ignore State Registrations

    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 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...

    • 35 s
    Legal Minute: 6 Crucial Mistakes in Informed Consent

    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: 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...

    • 59 s
    Legal Minute: What is informed consent in clinical trials?

    Legal Minute: What is informed consent in clinical trials?

    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...

    • 46 s
    Stop Risky Ads: Class Actions Could Cost You

    Stop Risky Ads: Class Actions Could Cost You

    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...

    • 22 min
    Legal Minute: How do drugs work?

    Legal Minute: How do drugs work?

    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.

    • 14 s

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