The FDA approval process is very stringent and requires several steps, including a pre-clinical phase, followed by three phases of clinical trials, then a thorough application before approval takes place. A very small percent of products actually make it through the pre-clinical phase and an even smaller percentage of products actually end up getting approved.
Instructions
1. The pre-clinical phase is the "discovery" part of the approval process and consists of three and a half years of testing in the lab. After this time has passed, an application is sent to the FDA to begin human testing. This is called an Investigational New Drug Application. The FDA will rarely grant "Fast Track Designation" to certain companies who demonstrate that their drug or biologic compound clearly addresses an unmet medical issue. All other drugs go on to the regular human trial process.
2. If the FDA approves the Investigational New Drug Application, then the drug moves into Phase 1 clinical trials, where 20-80 human subjects are tested. Researchers will look at how the drug affects the human subjects, what the side effects are, and how safe the drug is. Phase I trials usually last around 1 year.
3. If the Phase I results are efficacious, then the drug moves on to Phase II. During Phase II, a larger number of human subjects (100-300) is tested to see how well the drug actually works. Researchers will again look at the drug's safety profile and also what the benefits are. Phase II trials normally last around 2 years.
4. If a drug is proven to be safe and efficacious, then it will move along to the largest of the clinical trials in Phase III, where 1000-3000 patients are tested. During this phase, researchers take a closer look at the safety and effectiveness. They also review the "contraindications," or situations in which taking the drug would be dangerous to the person's health. Phase 3 normally takes 3 years and is the most comprehensive and stringent of the 3 phases.
5. If the drug passes Phase III as safe and effective, then a New Drug Application is filed with the FDA, which can take over 2 years to review. This application details all previous clinical trials and can be tens of thousands of pages long.
6. Once the FDA reviews the New Drug Application and approves it, the drug is officially approved and can begin to be marketed to the general population.
Tags: clinical trials, Drug Application, human subjects, pre-clinical phase, approval process, drug moves, efficacious then
