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U.S. Department of Health and Human Services

For Industry

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Regulatory Process

General Navigation Guide for Manufacturers of FDA-Regulated Products and Start-ups

What does FDA regulate?

What doesn’t FDA regulate? How do I contact the agencies that do?

 

Comment on Open Dockets:

FDA Open Dockets on Regulations.gov disclaimer icon

FDA Federal Registers

 

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. It serves as a neutral and independent resource for members of FDA-regulated industries when they experience problems with the regulatory process that have not been resolved at the center or district level. It works to resolve externally and internally generated problems for which 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

Drugs

Medical Devices

Radiation-Emitting Products

Tobacco Products

 

Laws and Regulations