Drugs undergo laboratory and animal testing to answer basic questions about safety. Drugs are tested on people to make sure they are safe and effective. FDA review teams thoroughly examine all of...

Sep 19, 2025 · This article reviews the primary development and approval phases that a drug or medical device must undergo before being approved by the FDA.

Generally, new drug applications (NDAs) or biologics license applications (BLA) are carefully reviewed before approval, and then drug performance is resubmitted to regulatory agencies for post-marketing …

The Drug Development and Approval Process The process of getting a drug to market, from first testing to final FDA approval, is summarized in figure 1 and described at greater length below.

Preclinical Research (/patients/drug-development-process/step-2- preclinical-research) Drugs undergo laboratory and animal testing to answer basic questions about safety.

Mar 19, 2025 · Understand the 5 key stages of drug development — from discovery to post-market safety. Learn how new drugs are approved by the FDA and brought to market.

Once researchers identify a promising compound for development, they conduct experiments to gather information on: How it is absorbed, distributed, metabolized, and excreted.

Aug 19, 2024 · What is the FDA approval process? The 4 phases of a drug approval process includes: The U.S. Food and Drug Administration's (FDA's) Center for Drug Evaluation and Research (CDER) …

Oct 30, 2024 · The primer, linked below, provides an overview of the FDA drug development process, highlighting the rapid advancements in therapeutics, vaccines and testing, and the role of the FDA in …

Mar 22, 2025 · A new medication must pass through five distinct stages in order to be considered a "success": 1) Discovery and Development; 2) Preclinical Research; 3) Clinical Trials; 4) FDA Drug …