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For Industry

Guidance, registration and listing, pay user fees, import programs, and more.

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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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Import Program

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

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.

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.

Industry Registrations, Submissions, Listings, and More

FDA Industry Systems

FDA Unified Registration and Listing Systems (FURLS), Prior Notice System Interface (PNSI), Import Trade Auxiliary Communication System (ITACS), and more.

FDA eSubmitter

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

Industry Registrations, Submissions, Listings, and More

CDER NextGen Portal

Available for alternative electronic submissions to CDER which are not required in eCTD.

Data Standards

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

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