FDA Postmarketing Requirements and Commitments

DOI https://doi.org/10.60592/gpv8-1w71

Source U.S. Food and Drug Administration

Drug companies must submit applications to the FDA and receive approval of the applications in order to market new prescription medicines (drugs and biologics). Drug and biologic applicants can agree to or be required to by the FDA to complete postmarketing studies before or after marketing approval. The postmarketing studies can be "important in improving the prescribing and use of the product; product quality; or consistency in product manufacturing. Postmarketing studies may confirm existing data, raise or answer questions, or provide new data....A company's agreement to conduct a study is called a postmarketing commitment."

More information is available in the Report to Congress Reports on Postmarketing Studies.

The FDA describes the Postmarketing Requirements and Commitments database file and provides a downloadable data file.

The FDA offers a Postmarketing Requirements and Commitments searchable database as well.

The FDA Postmarketing Requirements and Commitments data is offered here in SAS, Stata, and CSV formats to make the whole database a bit easier to use.

Updates and changes.