Table of Contents

CVM Updates
Investigations
FDA Veterinarian
FDA Consumer Magazine
Talk Papers/HHS News
Guidance
Meetings
Questions and Answers
Other Information
Biotechnology

CVM Updates

• FDA Receives NAS/NRC Report on Animal Biotechnology, August 21, 2002

Investigations with Bioengineered Animals

• CVM Letter to Land Grant University Presidents, May 13, 2003 | htm | | doc |

• CVM Letter to University of Illinois, September 29, 2003

• CVM Letter to University of Illinois at Urbana-Champaign, September 29, 2003

• FDA Investigates Improper Disposal Of Bioengineered Pigs, February 5, 2003

• FDA Form 483 Inspectional Observations: University of Illinois @ Urbana-Champaign | htm | | pdf |

FDA Veterinarian Newsletter

• CVM Participates in Pew Initiative Meeting on Transgenic Animals – January/February 2003

• How Transgenics are Produced – July/August 1999

• Will Transgenic Fish Be the First Ag-Biotech Food-Producing Animals? – May/June 1999

• Regulatory Issues In Agricultural Biotechnology – January/February 1998

• Food Safety Evaluation of Transgenic Animals – March/April 1996

FDA Consumer Magazine

• A New Kind of Fish Story: The Coming of Biotech Animals – January/February 2001

FDA Talk Papers and HHS News

• FDA Investigates Improper Disposal of Bioengineered Pigs, February 5, 2003

• Gene Therapy and Xenotransplation Clinical Trials, January 17, 2001

• Xenotransplation Guideline, September 20, 1996

Guidance

• Draft Guidance for Industry 153: Drugs, Biologics, and Medical Devices Derived From Bioengineered Plants for Use in Humans and Animals, September 2002

Meetings

• FDA's Center for Veterinary Medicine (CVM) and the Pew Initiative on Food and Biotechnology cosponsored a symposium entitled "Animal Cloning and the Production of Food Products -- Perspectives from the Food Chain“, on September 26, 2002. The symposium followed a two-day symposium being held by the Pew Initiative on Food and Biotechnology entitled "Biotech in the Barnyard: Implications of Genetically Engineered Animals".

  • The proceedings of the Animal Cloning symposium

  • The proceedings of the Biotech in the Barnyard symposium

• Transgenic Fish Developments: Are Transgenic Fish & Shellfish in Our Future?, presented at "Genetically Engineered Advances in Aquaculture: Reshaping America's Seafood Supply", San Francisco Seafood Show, November 4, 1999

• Transgenic Fish Developments: Are Transgenic Catfish in Our Future?, presented at Catfish Farmers of America Annual Meeting, New Orleans, February 1999

Questions and Answers

• Questions and Answers About Transgenic Fish – Information for Consumers, February 2000

Links to Other Information

• FDA Bioengineered Foods

  • CFSAN Biotechnology

  • CVM

    • Biotechnology in Animals and Feeds

    • Biotechnology in Aquaculture

• CBER

  • Xenotransplantation

  • Human Cloning

  • Human Cellular and Gene Therapy

  • Human Therapeutics

• University of Maryland AgNIC Agricultural Biotechnology Gateway

• U.S. Environmental Protection Agency

  • Office of Pesticide Programs

• CEQ/OSTP Assessment: Case Studies of Environmental Regulation for Biotechnology:

  • Introduction and Request for public Comment (pdf)

  • Case Study One: Salmon plus sidebar (pdf)

  • Case Study Four: Pharmaceutical producing animal plus sidebar (pdf)

• Biotechnology Industry Organization, Transgenic Animals Fact Sheet

• National Academy of Sciences (NAS) Report Animal Biotechnology: Science Based Concerns (2002)

• Food and Agricultural Organization of the United Nations

  • Food and Nutrition Division's Biotechnology Home Page

  • Glossary of Biotechnology for Food and Agriculture

• Code of Federal Regulations – 21 CFR Part 511--New Animal Drugs for Investigational Use, April 1, 2002

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