Postmarket Drug Safety Information for Patients and Providers: Selected Safety Regulations

•  – Labeling
  • 201.56 – Requirements on content and format of labeling for human prescription drug and biological product
    
  • Other labeling regulations
  • 208 – Medication Guides for Prescription Drug Products
  • 310.501 – Patient package inserts for oral contraceptives
  • 310.515 – Patient package inserts for estrogens
    
    
• 312 – Investigational New Drug (IND) Application
  • 312.32 – IND safety reports
  • 312.33 – Annual reports
  • 312.88 – Safeguards for patient safety
    
    
• 314 – Applications for FDA Approval to market a New Drug (NDAs)
  • 314.80 – Postmarketing reporting of adverse drug experiences
  • 314.81 - Other postmarketing reports
  • 314.97 - Supplements and other changes to an approved abbreviated application
  • 314.98 - Postmarketing reports
  • 314.520 – Approval with restrictions to assure safety use
  • 314.540 – Postmarketing safety reporting
  • 314.630 – Postmarketing safety reporting
    
    
• 601 – Biological Licenses
  • 601.12 - Changes to an approved application
  • 601.32 – General factors relevant to safety and effectiveness
  • 601.35 – Evaluation of safety
  • 601.93 – Postmarketing safety reporting

• 610 – General Biological Products Standards
  • 610.11 – General safety
    
    
• Related Links
  • Laws Enforced by the FDA and Related Statutes
  • FDA Federal Register Documents
  • CDER Guidances
  • CBER Guidelines
  • CDER Manual of Policies and Procedures (MAPPs)
  • CBER Manual of Regulatory Standard Operating Procedures and Policies