Regulatory Process
General Navigation Guide for Manufacturers of FDA-Regulated Products and Start-ups
What doesn’t FDA regulate? How do I contact the agencies that do?
Comment on Open Dockets:
FDA Open Dockets on Regulations.gov
Dispute Resolution Process
The FDA Office of the Ombudsman is the agency's focal point for addressing complaints and assisting in resolving disputes between companies or individuals and FDA offices concerning fair and even handed application of FDA policy and procedures. Its as a neutral and independent resource for members of FDA-regulated industries when they experience problems with the regulatory process that is not resolved at the center or district level. It works to resolve externally and internally generated problems for that there are no legal or established means of redress by finding approaches that are acceptable to both the affected party and to the agency. More about the Office of the Ombudsman.
Animal and Veterinary
Biologics
- CBER Ombudsman
- Guidance - Formal Dispute Resolution (Appeals Above the Division Level) (PDF - 30KB )
Drugs
- CDER Ombudsman
- Guidance - Formal Dispute Resolution (Appeals Above the Division Level) (PDF - 30KB )
Medical Devices
Radiation-Emitting Products
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Tobacco Products
Laws and Regulations
- Code of Federal Regulations (Title 21)
- Federal Food, Drug, and Cosmetic Act
- Other Laws Affecting FDA