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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.

• Code of Federal Regulations (Title 21)
• Federal Food, Drug, and Cosmetic Act
• Other Laws Affecting FDA

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.

• MedWatch
• 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
  • Approved Animal Drug Products
  • CVM's Policy & Procedures Manual
• Drugs
  • Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book)
  • Drug and Biologic Approval Reports
  • Drug Approval Reports by Month
  • New and Generic Drug Approvals
  • New Pediatric Information in Labeling (PDF - 1.15MB)
• Food
  • Food and Color Additives: Final Rules By Year
• Medical Devices
  • Recently Approved Devices
  • 510(k) Clearances
  • PMA Approvals 
• Radiation-Emitting Products
  • Radiation-Emitting Products Industry Assistance: Walk-through
• Vaccines, Blood, Biologics
  • Product Approvals and Clearances (Including Supporting Documents, Product/Manufacturer Lists, and Related Resources)

Manuals

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
  • Bacteriological Analytical Manual
  • Compliance Program Guidance Manual
  • Manual of Compliance Policy Guides
  • ORA Laboratory Manual
  • Pesticide Analytical Manual (PAM)

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.

• FDA Forms
• Forms & Reports