Points to Consider Guidance Documents
- Points to Consider in the Manufacturing and Testing of Monoclonal Antibody Products for Human Use. 1997.
- Draft Points to Consider in the Production and Testing of New Drugs and Biologicals Produced by Recombinant DNA Technology. 1985.
- Points to Consider in the Manufacture and Testing of Therapeutic Products for Human Use Derived from Transgenic Animals. 1995.
- Points to Consider on Plasmid DNA Vaccines for Preventive Infectious Disease Indications. 1996.
- Supplement to the Points to Consider in the Production and Testing of New Drugs and Biologicals Produced by Recombinant DNA Technology: Nucleic Acid Characterization and Genetic Stability. 1992.
Miscellaneous Guidance Documets
- Guidance for the Submission of Chemistry, Manufacturing and Controls Information and Establishment Description for Autologous Somatic Cell Therapy Products. 1997.
- Guidance for Industry for the Submission of Chemistry, Manufacturing and Controls Information for a Therapeutic Recombinant DNA-Derived Product or a Monoclonal Antibody Product for In Vivo Use. 1996.
- Guidance for Industry for the Evaluation of Combination Vaccines for Preventable Diseases: Production, Testing and Clinical Studies. 1997.
- Guidance for Industry – Changes to an Approved Application for Specified Biotechnology and Specified Synthetic Biological Products. 1997.
- Guidance for Industry: Content and Format of Investigational New Drug Applications (INDs) for Phase I Studies of Drugs, including Drugs Well-Characterized, Therapeutic, Biotechnology-Derived Products. 1995.
- FDA Guidance Concerning Demonstration of Comparability of Human Biological Products, Including Therapeutic Biotechnology-Derived Products. 1996.
- Supplemental Guidance on Testing Replication Competent Retrovirus in Retroviral Vector-Based Gene Therapy Products and During Follow Up of Patients in Clinical Trials Using Retroviral Vector. 2000.
- PHS Guideline on Infectious Disease Issues in Xenotransplantation. 2001