For Industry

Import Alerts

Import Alerts report and disseminate import information (problems, violative trends, etc.) providing for more uniform and effective import coverage

At-a-glance tables to point you to the regulations you need

Resources on the petition process for color additive approval

User Fees

Fees support the surveillance of human and animal drugs, medical and mammography devices, color additives, and exports

Small Business Guide to working with the FDA

Import Program

Information for FDA personnel, import brokers, wholesalers, retailers and consumers about import products

Color Additives

Color additive approval and certification, using color additives in different products, safety information, and more

Guidance Documents

Represent FDA's current thinking on a topic; they do not create/confer rights or bind FDA or the public

Promoting the development of promising products for the diagnosis or treatment of rare diseases or conditions

Data Standards

Information about the FDA Data Standards Council and other data standards topics

For individuals and companies experiencing problems with the regulatory process or with the application of FDA policies or procedures

Information on how to submit documents to FDA electonically.

FDA eSubmitter

An electronic submissions program for the device, radiological health and blood regulated industries.