Inside the FDA: How Your Medicine Gets Made

Most people take prescribed medications without realizing the long, complex process behind their approval.

In this presentation, Dr. Dan Gordin traces that journey from early scientific discovery to final FDA approval.

It begins with key moments in U.S. history when drug-related tragedies exposed gaps in safety oversight. The 1937 sulfanilamide disaster led to the 1938 Food, Drug, and Cosmetic Act, expanding federal authority over drug safety. Later, the thalidomide tragedy of the early 1960s prompted the 1962 Kefauver–Harris Amendments, requiring manufacturers to prove both safety and effectiveness before marketing drugs.

The program also outlines the FDA’s role in protecting public health by regulating medications and other consumer products, ensuring they meet standards for quality, safety, and efficacy.

The presentation then follows the development of a new drug—from laboratory discovery through preclinical testing and multiple phases of clinical trials—to evaluate safety and effectiveness in humans. It concludes with the FDA’s rigorous review of a drug’s benefits, risks, clinical data, and manufacturing standards before approval.

Overall, the talk highlights the complex, often unseen process that brings a drug from initial discovery to a patient’s medicine cabinet.

Dr.Dan Gordin is a pharmaceutical executive with over 30 years of experience in drug development, including five years serving as a Clinical Pharmacology Reviewer at the Food and Drug Administration (FDA). He has a doctorate in Pharmaceutical Sciences from the Medical University of South Carolina with a focus on Clinical Pharmacology and Pharmacokinetics.  

His expertise encompasses both early and late-phase drug development, with a primary focus on the formulation of regulatory strategy.  He has worked across a variety of therapeutic areas, including neuroscience, autoimmune diseases, infectious diseases, dermatology, solid organ transplantation, women's health, and oncology.  Currently, Dr. Gordin serves as a regulatory affairs consultant and a lecturer at Rutgers University and the Medical University of South Carolina.

This program is made possible with the support of The Friends of the Livingston Public Library.