Para industria
Alertas de importación - 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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Alertas de importación 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
For Industry Topics
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.
ColorantesColor additive approval and certification, using color additives in different products, safety information, and more
Data StandardsInformation about the FDA Data Standards Council and other data standards topics
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
Small Business Guide to working with the FDA
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.
Programa de importaciónInformation for FDA personnel, import brokers, wholesalers, retailers and consumers about import products.
Industry Notices and Guidance DocumentsRepresent FDA's current thinking on a topic; they do not create/confer rights or bind FDA or the public
Tarifas del usuarioFees support the surveillance of human and animal drugs, medical and mammography devices, color additives, and exports
Recursos para usted
Approvals of FDA-Regulated Products MedWatch: The FDA Safety Information and Adverse Event Reporting Program Retiro de productos del mercado y alertas de seguridad Inspection, Compliance, Enforcement, and Criminal Investigations Driving Biomedical Innovation: Initiatives for Improving Products for Patients Pruebas clínicas Guía para la industria Noticias correo e.
