The Rx Factor

Ashish Choksi
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  • Education
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A deep dive into the science, regulations, and innovations shaping the future of medicine. From drug development and clinical trials to regulatory affairs and breakthrough technologies like AI in pharma, this podcast breaks down the complex world of healthcare into clear, actionable insights. Ideal for professionals, students, and anyone curious about how medicines are discovered, developed, and delivered to the world.

Episodes

  1. 08/15/2025

    OTC Uncovered: How Non-Prescription Drugs Get FDA Approval

    From painkillers to allergy relief, over-the-counter (OTC) medicines are part of daily life — but how do they get approved for safe use without a prescription? In this episode of The Rx Factor, we break down the FDA’s OTC Monograph system, the NDA pathway, and the science behind Rx-to-OTC switches. You’ll learn what makes a drug “OTC-worthy,” why labeling is critical, and how the future of OTC regulation is evolving with new technology.

  2. 08/03/2025

    IND: The First Gatekeeper in Drug Development

    Before a drug ever reaches a human, it must pass one of the toughest regulatory gates: the Investigational New Drug (IND) application. In this episode of The Rx Factor, we break down what an IND really is, what goes inside it, why it’s critical for patient safety, and how it opens the door to clinical trials. From preclinical data and CMC to emergency INDs and safety reporting — discover the science and strategy behind this crucial first step in drug development.

  3. 07/31/2025

    The FDA two Powerhouses CDER vs CBER

    What exactly is a drug — and who at the FDA makes sure it's safe? In this episode of The Rx Factor, we break down the definition of a drug, explore how the FDA regulates medicines and biologics, and explain the vital roles of CDER and CBER. Perfect for healthcare professionals, students, and curious minds alike.

  4. 07/25/2025

    Biosimilars and Beyond

    In this episode of The Rx Factor, we dive deep into the world of biosimilars — what they are, how they differ from traditional biologics, and the growing role of interchangeable biosimilars in improving access and reducing healthcare costs. We also break down the FDA’s Biosimilar Product Development (BPD) meetings, their types, and why they’re crucial to the approval process. Plus, we explore how biosimilars are evolving globally and what the future holds for this rapidly advancing field.

  • 4 Episodes

About

A deep dive into the science, regulations, and innovations shaping the future of medicine. From drug development and clinical trials to regulatory affairs and breakthrough technologies like AI in pharma, this podcast breaks down the complex world of healthcare into clear, actionable insights. Ideal for professionals, students, and anyone curious about how medicines are discovered, developed, and delivered to the world.

Information

  • Creator
    Ashish Choksi
  • Years Active
    2025
  • Episodes
    4
  • Rating
    Clean
  • Copyright
    © Ashish Choksi
  • Show Website
    The Rx Factor