The Food and Drug Administration's approval process is complex and can take many years. There are several steps involved, including a preclinical testing trial phase followed by three phases of human clinical trials. It takes an average of 12 years and $350 million to get a drug approved and on the shelf, according to Drugs.com.
Instructions
1. Enter preclinical testing, the first phase of the FDA approval process. It can take as long as six to seven years. Here you will engage in animal testing for the drug compound. A very small percentage of products being tested will complete the next step, which involves sending an investigational new drug application to the FDA for approval to begin testing on humans. If the FDA accepts the IND then the drug moves on to phase 1 of the human clinical trials.
2. Once the FDA approves the investigational new drug application, enter the first phase of clinical trials, where research on healthy individuals is conducted to determine the safety in humans. Anywhere from 20 to 80 humans are tested during this phase, according to drugs.com. Phase 1 trials can last from one to two years.
3. If the drug passes phase 1, move along to phase 2 of clinical testing. During phase 2 you will test a greater number of humans--100 to 300--to determine the efficacy of the drug, according to drugs.com. Conduct these efficacy trials on volunteer human subjects who make up the potential target audience of the drug. At the end of phase II, review the development process with the FDA, and if you are granted approval you will move along to phase 3.
4. During phase 3, test anywhere from 1,000 to 3,000 patients. During this phase, which is the most arduous and expensive, scrutinize the safety and efficacy of the drug. Analyze side effects and potential risks closely during phase 3. This phase can last upwards of three years, according to drugs.com.
5. Once you pass all three of these human clinical trials, file a new drug application with the FDA. This application reviews all of the clinical trials conducted. It may be up to 100,000 pages long and can take years to review. There are sometimes special circumstances when you can accelerate this process, such as when there is a clear medical need for the product. The FDA will review your NDA and determine whether to declare that the drug is safe and effective.
Once the FDA reviews the new drug application and approves it, your product is officially approved and you can begin to market it to the general population. At this point, physicians can begin prescribing the drug as well.
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