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...

Feb 16, 2026 · A definitive walkthrough of every stage in the pharmaceutical development process—with timelines, costs, success rates, and strategic deal implications at each phase.

Learn why the drug development timeline averages 10-15 years. This guide details each stage from discovery and preclinical studies to all clinical trial phases

Oct 23, 2023 · To be deemed a “success,” a new drug must make it through five specific phases: 1) discovery and development, 2) preclinical research, 3) clinical research, 4) FDA review, and 5) safety …

Though you see new drugs being advertised in the United States every day, each of those drugs has to pass through five key stages of the drug development process, outlined below.

During the phases of the IND, the manufacturer can obtain accelerated development/review of the drug. Other accommodations for usage prior to approval include treatment IND and parallel tracking. Once …

There are five critical steps to the drug development process in the United States. These steps are outlined in the diagram and text below. Step 1: Discovery and Development – Research for a new …

Jun 17, 2025 · Upon approval of an IND application, the drug candidate moves into clinical trials, where it is tested in humans for the first time. This process is structured into three sequential phases, each …

May 27, 2025 · Drug development is a process that spans many years, from the initial phase of identifying potential drug candidates to testing for safety and efficacy in preclinical and clinical trials, …

Mar 19, 2025 · Clinical research is conducted to test the safety and efficacy of drugs in humans. These are divided into 4 stages: each stage is designed to gather specific data to understand drug …