For Industry

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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 in a user-friendly format.

Small Business Assistance

Small Business Guide to working with the FDA

Dispute Resolution

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

Color Additives

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

Developing Products for Rare Diseases & Conditions

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

User Fees

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 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.

Data Standards

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

Industry Notices and Guidance Documents

Information for industry about FDA guidance documents and notices to industry

Page Last Updated: 10/02/2015
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