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.

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.

Información para la Industria

Obtenga información sobre las regulaciones de la FDA

Drugs

Food

Medical Devices

Vaccines, Blood, & Biologics

Tobacco Products

Animal & Veterinary

Cosmetics

Radiation-Emitting Products

483 Inspection Reports

CFR Title 21

Orange Book

510(k) Premarket Notification

Get Email Updates

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