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U.S. Department of Health and Human Services

For Industry

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

 

Laws and Regulations

The Food and Drugs Act of 1906 was the first of more than 200 laws that constitute one of the world's most comprehensive and effective networks of public health and consumer protections. You can find online some of the laws and regulations governing FDA-regulated industries.

 

Safety Information

FDA provides post market safety information for some FDA-approved drugs online as well as information about the Risk Evaluation Mitigation Strategies (REMS) approved by the agency.

 

Approvals and Clearances

FDA posts information about products that the agency has approved or cleared for marketing.

 

Manuals

FDA posts manuals that set forth policies and procedures that govern some of the agency's activities.

 

Forms

This collection includes forms for applications and submissions, reports and accountability, certifications, and inspections. Forms are listed by topic area (e.g., Cosmetics, Foods, Human Drugs, Safety & Problem Reports, Field Operations, etc.) or can be sorted alphabetically or numerically. The most frequently accessed forms by drug sponsors are included in a separate link.