For Industry
Import Alerts
Import Alerts report and disseminate import information (problems, violative trends, etc.) providing for more uniform and effective import coverage
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.
Color 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
Dispute ResolutionFor individuals and companies experiencing problems with the regulatory process or with the application of FDA policies or procedures
Guidance DocumentsRepresent FDA's current thinking on a topic; they do not create/confer rights or bind FDA or the public
Import ProgramInformation for FDA personnel, import brokers, wholesalers, retailers and consumers about import products
Small Business Guide to working with the FDA
User FeesFees support the surveillance of human and animal drugs, medical and mammography devices, color additives, and exports
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.
Data StandardsInformation about the FDA Data Standards Council and other data standards topics
FDA Basics for IndustryFDA 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.