How Drugs Become FDA Approved: A TLDR Guide

The journey from promising molecules in a laboratory to a prescribed medication in your local pharmacy is a complex and meticulously regulated process. Ever wondered how drugs make their way through the rigorous vetting process of the Food and Drug Administration (FDA)? In this article, we delve into the TLDR (Too Long; Didn't Read) version of how drugs become FDA-approved.

Each step in the drug approval process is laden with scientific scrutiny, ethical considerations, and regulatory requirements. Understanding this process not only sheds light on the journey of a drug, but also underscores the paramount importance of safety and efficacy in pharmaceutical development, and explains why drug prices are so high in the US in comparison to other countries.

Steps in the process: 

Pre-clinical trials: The development of new drugs begins with discovery, where researchers use methods like computer analysis and study of disease processes to create compounds, followed by extensive lab testing to evaluate their effects. As the number of approved drugs grows, finding new candidates becomes increasingly complex. Successful compounds then undergo preclinical research, involving lab and animal testing to confirm their safety and effectiveness, in compliance with strict regulations. With positive preclinical outcomes, developers submit an Investigational New Drug Application (IND) to the FDA, detailing human trial plans for safety review. This process, from concept to potential clinical trial, reflects the rigorous evaluation to ensure the viability and safety of new drugs. 

Upon IND approval, the drug enters clinical trials involving humans. These trials are conducted in three phases:

• Phase 1 tests the drug on a small group of people for safety and dosage.
• Phase 2 expands the study to more people to further assess safety and effectiveness.
• Phase 3 involves a larger group of people to confirm effectiveness, monitor side effects, and compare it to commonly used treatments.

New Drug Application (NDA): After successful clinical trials, the drug developer files an NDA with the FDA. The NDA includes all data from the drug's development, including preclinical and clinical trial results. The FDA then reviews the NDA to decide whether the drug is safe and effective for its intended use.

FDA Review: The FDA's review process involves a thorough evaluation of the NDA, including the drug's proposed labeling and manufacturing process. The FDA may ask for more information or even additional studies.

FDA Approval: If the FDA determines that the drug's benefits outweigh its risks for the intended use, it approves the drug. The approval allows the drug to be marketed in the United States. The FDA continues to monitor the drug's safety, requiring post-marketing studies in some cases to gather additional information.

This article captures the essence of the drug approval process by the FDA, focusing on the key steps and considerations involved in bringing a new drug from discovery to market.

Written by Susan Egbert.

Edited by Margaret Du.

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