The Basics of How a Drug Gets FDA Approved

Obtaining FDA-approved drugs is expensive, time-consuming, and risky. Only one in five drugs actually takes care of the process, and the costs are very high. If the drug is successful and the disease that is cured is widespread, the potential for sale could be enormous.

You may look at Wizmed for tentative FDA drug approvals.

After a drug has been synthesized in the laboratory or purified from natural sources, the next step is usually animal testing. Commonly used animals include mice or rats. This is known as the pre-clinical testing phase.

If successful, applications for new drugs (IND) are submitted to the Food and Drug Administration (FDA). In the IND application, the protocol is for human experimentation. The FDA can dispute the protocol, but if not after 30 days, manufacturers can start testing.

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Clinical studies are carried out in 3 stages. In phase 1, the drug is given to healthy volunteers who do not have the disease to be treated. It is used to check safety and to determine dosage. After Phase 2 is complete, the medicine will be given to people with this disease and also checked for safety and side effects. The numbers in this phase are small.

In phase 3, the drug will be given to a large number of people with the disease so that real statistical results can be obtained. The period for all 3 phases averages 5 years, but may be longer if the drug is complex or if there are not many patients with disease tested.

After successfully passing phase 3, manufacturers submit new drug applications (NDAs) to the FDA. It is comprehensive and includes all study results.