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U.S. Department of Health and Human Services

For Industry

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For Industry Topics

FDA Basics for Industry

FDA Basics for Industry is aimed at improving communication between FDA and industry by making basic information about the regulatory process more accessible to industry in a user-friendly format.

Color Additives

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

Data Standards

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

Developing Products for Rare Diseases & Conditions

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

Dispute Resolution

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

Small Business Assistance

Small Business Guide to working with the FDA

Electronic Submissions Gateway

Information on how to submit documents to FDA electronically.

FDA eSubmitter

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

Import Program

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

Industry Notices and Guidance Documents

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

User Fees

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