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FDA

The FDA or Food and Drug Administration is the body that approves all new drugs that are sold in the United States.

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Expanded Definition

The Food and Drug Administration regulates the drugs that are sold in the United States. Before a new drug can be brought to market, it must meet the FDA standards for proof of safety and effectiveness.

For a new drug this typically involves the assembly of pre-clinical data, the submission of an Investigational New Drug Application (INDA) and the conduct of multiple human trials. These trials are referred to by their phases.

Phase I trials are used to establish that the drug is safe for use in human beings and to establish the Maximum Tolerated Dose (MTD).

Phase II trials are used to make an initial finding of efficacy for the new drug. If the Phase II trials are successful then the drug will be advanced to Phase III.

Phase III trials are used to establish that a new drug is effective up to scientific standards of statistical significance. The FDA typically requires two successful phase III trials before approving a drug for sale to the public.

When the drug developer believes that the FDA's requirements have been met the results are submitted as a New Drug Application (NDA).

The FDA then takes a number of months to review the application. Prescription Drug User Fee Act (PDUFA) prescribes the time frame in which the FDA is required arrive at its decision. This act also requires the applicant to pay the cost of the evaluation.

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