How long is fda approval process

Once approved, the drug may be marketed with FDA regulated labeling. The FDA also gathers safety information as the drug is used and adverse events are reported, and it will occasionally request changes in a labeling or will submit press releases as new contraindications arise. If adverse events appear to be systematic and serious, the FDA may withdraw a product from the market.

Over time there has been a clear tendency for FDA regulations and requirements to expand and multiply. In , the typical drug underwent thirty clinical trials involving about fifteen hundred patients.

By the mids, the typical drug had to undergo more than sixty clinical trials involving nearly five thousand patients. This stage also involves a review by the FDA to determine if the professional package labeling of the product adequately educates health professionals and the general public, including information on its proper use and potential risks or side effects. In addition, the FDA inspects the facilities where the drug or product will be manufactured.

Even after approval and appearance on the market, the FDA continues to monitor for serious adverse events and other dangers to the public. If this independent and unbiased review establishes that a drug's health benefits outweigh its known risks, the drug is approved for sale. The center doesn't actually test drugs itself, although it does conduct limited research in the areas of drug quality, safety, and effectiveness standards. Before a drug can be tested in people, the drug company or sponsor performs laboratory and animal tests to discover how the drug works and whether it's likely to be safe and work well in humans.

Next, a series of tests in people is begun to determine whether the drug is safe when used to treat a disease and whether it provides a real health benefit. For more information about the drug development and approval process, see How Drugs Are Developed and Approved. The drug approval process takes place within a structured framework that includes:. As a science-led organization, FDA uses the best scientific and technological information available to make decisions through a deliberative process.

In some cases, the approval of a new drug is expedited. Accelerated Approval can be applied to promising therapies that treat a serious or life-threatening condition and provide therapeutic benefit over available therapies.

This approval pathway is especially useful when the drug is meant to treat a disease whose course is long, and an extended period of time is needed to measure its effect. If further trials fail to verify the predicted clinical benefit, FDA may withdraw approval. Since the Accelerated Approval pathway was established in , many drugs that treat life-threatening diseases have successfully been brought to market this way and have made a significant impact on disease course.

A number of targeted cancer-fighting drugs also have come onto the market through this pathway. More information on Accelerated Approval is here.