How are new drugs approved by FDA?

Since 1938, every new drug has been the subject of an approved New Drug Approval (NDA) application before it is sold in the U.S. The NDA application is the vehicle through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing in the U.S. The data gathered during the animal studies and human clinical trials of an Investigational New Drug (IND) become part of the NDA.
The goals of the NDA are to provide enough information to permit FDA reviewers to reach the following key decisions:

• whether the drug is safe and effective in its proposed use or uses.
• whether the benefits of the drug outweigh the risks.
• whether the drug’s proposed labeling (package insert) is appropriate and what it should contain.
• whether the methods used in manufacturing the drug and the controls used to maintain the drug’s quality are adequate to preserve the drug’s identity, strength, quality, and purity.

Phases of Clinical Trials
After a drug is shown to have promise in terms of effectiveness and an adequate measure of safety for humans during animal studies, it moves into clinical trials to test for effects in humans. Clinical trials are categorized into the following phases:

1. Phase I - Small studies, usually involving 20 to 80 patients, for the purpose of determining safety.
2. Phase II - Larger studies, involving up to several hundred subjects, to further explore safety and to determine effective dosage for a specific indication.
3. Phase III - Still larger studies, involving up to several thousand subjects, for the purpose of gathering additional information about safety, efficacy, and dosage that is needed to determine the overall benefit-risk relationship of the drug and to characterize the drug for its intended use.
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