In the United States, all medications except natural remedies and supplements, must go through an approval process before they can be made available to people. The Food and Drug Administration (FDA) is responsible for ensuring that these drugs, whether they are prescription or over the counter, are effective and safe. As part of the FDA, the Center for Drug Evaluation and Research (CDER) controls the introduction of drugs to the market.
This is the beginning of the whole approval process. The company spends years developing a drug. They test compounds and ingredients to determine multiple factors including effectiveness and dosages as a starting point.
The company submits an application to the FDA for investigative permission. The drug is then called an investigational new drug (IND). If it is approved, the drug begins the road to clinical trials. This first phase lasts about a year and involves between 20 and 80 healthy patient volunteers to test it. The volunteers are given slowly increasing doses to help establish the properties of the drug and its safety for people.
In the second phase, 100 to 300 patient volunteers are used. This phase lasts about two years. Its purpose is to determine the potential effectiveness, delivery method, and intervals of dosing for the IND. The volunteers are a targeted group, usually comprised of patients who suffer from the condition the drug is supposed to treat.
If the IND makes it through phase 2, it is now in the final step of clinical trials. This phase is often the longest, averaging between two and ten years. About 1,000 to 3,000 current patients of hospitals and clinics are involved. They are monitored for side effects, adverse reactions, and overall effectiveness.
After Phase 3, the company must then submit a New Drug Application (NDA). This application will contain all the data collected during the development and three phrases. It includes information about the composition, manufacturing process, and proposed labeling of the drug. From this point the FDA reviews the data, conducts an independent study, and then makes a recommendation. This process can take between six and twelve months.
The FDA can deny or approve an application. If it is denied, the company is provided with reasons why and what can be done for an approval. An approval means the drug can be put on the market.
By Eszter Hazai, PhD Google+