The Rx Factor

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 re...

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 scie...

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.

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...