Export requirements apply to investigational new drugs (INDs) as follows: Exporting Investigational New Drugs to a Listed CountrySection 802(c) of the Federal Food Drug and Cosmetic […]

Drugs made in the U.S. are not always approved by FDA but may be approved by regulatory authorities in other countries. Exporters must comply with U.S. […]

FDA works to help assure safe and quality drugs are exported from the U.S. for use around the world. The agency reviews thousands of electronic certificate […]

Who Is the Audience for This Website? FDA’s generic drug-specific labeling resources are primarily directed to industry staff who develop generic drug labeling. For more information […]

This page is intended to assist industry when making certain regulatory submissions in electronic format to the FDA’s Adverse Event Reporting System (FAERS) database for the […]

This list contains GDUFA facility payments received by the Agency. The following table explains the terms used in the list: Column Description Fiscal Year The Fiscal Year […]

Docket Number: FDA-2014-D-0092 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research This technical specifications document represents the Food and Drug Administration’s (FDA’s) current thinking […]