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.
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.
- Recalls, Market Withdrawals, and Safety Alerts
- Index to Drug-Specific Information
- Medication Guides
- Approved Risk Evaluation and Mitigation Strategies (REMS)
- Enforcement Reports
Approvals and Clearances
FDA posts information about products that the agency has approved or cleared for marketing.
- Animal Drugs
- Medical Devices
- Radiation-Emitting Products
- Vaccines, Blood, Biologics
- Product Approvals and Clearances (Including Supporting Documents, Product/Manufacturer Lists, and Related Resources)
FDA posts manuals that set forth policies and procedures that govern some of the agency's activities.
- Regulatory Procedures Manual
- Investigations Operations Manual
- Manual of Policies and Procedures (CDER)
- Standard Operating Policies and Procedures (CBER)
- Staff Manual Guides
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.