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U.S. Department of Health and Human Services

About FDA

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Adverse Drug Experience Reporting

On December 23, 2007 a significant change to the postmarketing reporting requirements for drug products goes into effect. Chapter VII, SubChapter H, Section 760 of the Food, Drug, and Cosmetic (FD&C) Act establishes new adverse event reporting requirements which apply to the manufacturers, packers, and distributors whose names appear on the labels of over-the-counter (OTC) or behind-the-counter (BTC) drugs marketed in the United States. Please see links below for reference documents related to these new requirements.


To ensure consumer safety, the FDA collects information on adverse drug experiences that occur after a prescription medication is approved or marketed. The Division of Compliance Risk Management and Surveillance enforces the Postmarketing Adverse Drug Experience (PADE) Reporting Requirements in an effort to ensure that the FDA is receiving data on rare, latent, or long-term drug effects not identified in premarket testing. The division also ensures that PADE reports are accurate, complete, and submitted in a timely manner. The division communicates the agency's compliance expectations to the pharmaceutical industry through outreach efforts, including presentations to various industry associations and agency counterparts and training sessions at the FDA’s Basic Drug School for investigators.

Drug firms, health care professionals, and consumers submit PADE reports to FDA for domestic and foreign adverse events associated with FDA-regulated drug products. Based on these reports, the division identifies domestic and foreign firms, including New Drug Application holders and drug manufacturers, packers, and private-label distributors, for inspection. The division uses a risk-based approach to identify firms for inspection that focuses on drugs that pose a significant health risk to consumers and other priority issues affecting the public’s health. The findings of the inspections are evaluated to determine if regulatory action is necessary.

Drug application holders and certain manufacturers, packers, and distributors for prescription and non-prescription drugs are required to submit specific adverse event and drug safety information to FDA. These requirements are set forth in the Federal Food, Drug, and Cosmetic Act (FD&C Act) and Title 21 of the Code of Federal Regulations (CFR). Final and draft guidances are available which clarify the FDA's expectations for meeting the regulatory requirements.

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