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 […]

For Immediate Release: March 29, 2024 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:  On Thursday, […]

Docket Number: FDA-2016-D-1280 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research This technical specifications document is to assist interested parties in electronically submitting […]

Laws, Regulations, Guidances, and Compliance Letters Some of the links from this page take you to other government web sites. Once you leave this page, click […]