National Toxicology Program

U.S. Food and Drug Administration

FDA Documents may also be found via the Agency Guidelines and Regulations Search Page

• U.S. Code of Federal Regulations (CFR):
  
  • 21CFR211.167 - Current Good Manufacturing Practice for Finished Pharmaceuticals: Special Testing Requirements [PDF]
    
  • 21CFR610.13 - General Biological Products Standards: Purity [PDF]
    
  • 21CFR610.9 - General Provisions: Equivalent methods and processes [PDF]
    
    
• Guideline on Validation of the Limulus Amebocyte Lysate Test as an End-Product Endotoxin Test for Human and Animal Parenteral Drugs, Biological Products, and Medical Devices (December 1987) [PDF]


• Guidance for Industry: Considerations for Plasmid DNA Vaccines for Infectious Disease Indications (November 2007) [PDF]


• Guidance for FDA Reviewers and Sponsors: Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs) (April 2008) [PDF]


• Guidance for FDA Reviewers and Sponsors: Instructions and Template for Chemistry, Manufacturing, and Control (CMC) Reviewers of Human Somatic Cell Therapy Investigational New Drug Applications (INDs) (April 2008) [PDF]


• Guidance for Industry and/or for FDA Reviewers/Staff and/or Compliance: Preparation of a Premarket Notification Application for a Surgical Mesh (March 1999) [PDF]

International Organization for Standardization (ISO)

• ISO 10993-11 - Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (First edition 1993-12-15)
  
  

United States Pharmacopeia (USP) 28-NF23

• (85) - Bacterial Endotoxins Test [PDF]


• (151) - Pyrogen Test [PDF]


• (1041) - Biologics [PDF]

European Pharmacopoeia 5.0

• 2.6.8. Pyrogens [PDF]


• 2.6.14. Bacterial Endotoxins [PDF]

European Pharmacopoeia 5.2

• 07/2005:0520 Parenteral Preparations [PDF]