For Industry
User Fees - Pay user fees for pre-market review, establishment/facility registration, export certificates, color additive certificates, tobacco penalties, and FOIA requests.
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User Fees Import Alerts - Import Alerts prevent products that may not meet FDA standards from being distributed in the U.S. and make importers responsible for ensuring products aren't adulterated or misbranded.
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Import Alerts Color Additive Inventories - At-a-glance tables to point you to the regulations you need
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Color Additive Inventories 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.
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FDA Basics for Industry
Navigate the For Industry Section
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.
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
Links to prepare cover sheets and pay user fees for pre-market product reviews, and to pay for establishment/facility registrations, export certificates, color additive certificates, tobacco civil money penalties, and FOIA requests.
Electronic Submissions GatewayInformation 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
Industry Notices and Guidance DocumentsInformation for industry about FDA guidance documents and notices to industry
Resources for You
Approvals of FDA-Regulated Products MedWatch: The FDA Safety Information and Adverse Event Reporting Program Recalls, Market Withdrawals, & Safety Alerts Search for FDA Guidance Documents Inspection, Compliance, Enforcement, and Criminal Investigations Driving Biomedical Innovation: Initiatives for Improving Products for Patients Clinical Trials and Human Subject Protection Get Email Updates