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FDA Drug Approval Process

As you might imagine, there are several phases to the process of getting a drug approved by the FDA (Food and Drug Administration) for sale to the public.

Pre-Clinical Testing: In this initial phase, the drug is developed, animal tests are performed, and an institutional review board studies the product. If the recommendations are positive, then an application to the FDA is submitted and clinical drug trials begin.

Phase 1: This is the first time that a new drug is tested on humans. The purpose of these studies is to learn more about how the drug works in humans, how effective it may be and what potential side effects may exist.

Phase 2: This stage is to determine the effectiveness of a drug in treating patients with a specific disease or condition, and to closely examine and assess common short-term side effects or risks.

Phase 3: At this point, large scale clinical trials are performed to provide more information about the effects and safety of the drug, allowing scientists to better gauge their findings in a larger test population.

Once a drug is approved by the FDA, it goes on the market as soon as the manufacturing company can get its production and distribution systems in place.

The FDA estimates that it takes a little over 8 years for a drug manufacturer to acquire FDA approval for a new product. There are, however, circumstances such as terminal illness in which investigational drugs may be administered to the public even before they are approved for marketing.

Despite their best efforts, however, some drugs can have very dangerous side effects that may not have been clearly understood during the testing processes. If you or a loved one has suffered an injury from a defective or recalled drug, please contact the drug litigation attorneys at Schlichter, Bogard & Denton today, for a free initial consultation.

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