For Industry
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How to pay user, registration, facility, certificate, and other fees. Includes cover sheet submission, invoice payment, and refund requests.
Small Business AssistanceSmall Business Guide to working with the FDA
Dispute ResolutionFor individuals and companies experiencing problems with the regulatory process or with the application of FDA policies or procedures
Color AdditivesColor additive approval and certification, using color additives in different products, safety information, and more
Developing Products for Rare Diseases & ConditionsPromoting the development of promising products for the diagnosis or treatment of rare diseases or conditions
Information on how to submit documents to FDA electronically.
FDA eSubmitterAn electronic submissions program for the device, radiological health and blood regulated industries.
Import ProgramInformation for FDA personnel, import brokers, wholesalers, retailers and consumers about import products.
Data StandardsInformation about the FDA Data Standards Council and other data standards topics
FDA Basics for IndustryBasic information about the regulatory process in an accessible and user-friendly format.
Industry Notices and Guidance DocumentsInformation for industry about FDA guidance documents and notices to industry