Import Program
Information for FDA personnel, import brokers, wholesalers, retailers and consumers about import products.
Industry Notices and Guidance Documents
Information for industry about FDA guidance documents and notices to industry.
User Fees
How to pay user, registration, facility, certificate, and other fees. Includes cover sheet submission, invoice payment, and refund requests.
FDA Basics for Industry
Basic information about the regulatory process in an accessible and user-friendly format.
Small Business Assistance
Contacts for small business assistance.
Developing Products for Rare Diseases & Conditions
Promoting the development of promising products for the diagnosis or treatment of rare diseases or conditions.
Color Additives
Color additive approval and certification, using color additives in different products, safety information, and more.
Dispute Resolution
For individuals and companies experiencing problems with the regulatory process or with the application of FDA policies or procedures.
FDA Industry Systems
FDA Unified Registration and Listing Systems (FURLS), Prior Notice System Interface (PNSI), Import Trade Auxiliary Communication System (ITACS), and more.
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.
Data Standards
Information about the FDA Data Standards Council and other data standards topics.