The Food and Drug Administration’s Prescription Drug Approval Process

The Food and Drug Administration’s Prescription Drug Approval Process

The Food, Drug, and Cosmetic Act (Act) regulates foods, drugs, medical devices and cosmetics. The Act established the Food and Drug Administration (FDA), which has responsibility to assure that new drugs are safe and effective.

Definition of New Drug


All new drugs require approval by the FDA before they can be marketed. A new drug is defined as a drug that is not generally recognized among scientific experts as safe and effective for the use suggested in the labeling. The approval process can take a long time and cost a lot of money.

New Drug Testing


Initially, the unapproved drug is tested on laboratory animals. If the testing is successful, the manufacturer can apply for an investigational new drug application with the FDA. The FDA then decides if human clinical tests should be allowed. The investigational new drug application automatically takes effect if the FDA fails to act. A manufacturer can then begin clinical testing of the drug on human beings.

New Drug Application or Abbreviated New Drug Application


Once the clinical tests are completed, the drug manufacturer is required to submit a new drug application or an abbreviated new drug application to the FDA. The drug application includes an analysis of the drug and test data showing that the drug is safe and effective. The application must also include the uses of the drug and the proposed labeling for the new drug. Any written material that a manufacturer provides about the drug is also subject to FDA review. The label can only list uses for which the manufacturer has shown substantial evidence of the drug’s safety and effectiveness. The label also has to include dosage, directions for use, and any known warnings or contraindications. The FDA will approve the new drug for sale if the manufacturer shows substantial evidence of the drug’s safety and effectiveness.

Good Manufacturing Practices


The FDA also has authority to inspect facilities that manufacture, package, or store drugs to ensure that the drugs are not adulterated (contaminated). The FDA has adopted minimum requirements for drug manufacturing. These regulations specify what records and reports have to be kept and give production, packaging and labeling controls.

Monitoring Adverse Drug Events


After approval, the FDA continues to monitor new drugs through a reporting system. Drug manufacturers and health professionals are required to report adverse experiences that are allegedly caused by new drugs that have FDA approval.

Copyright 2011 LexisNexis, a division of Reed Elsevier Inc.

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