University of Maryland AgNIC Agricultural Biotechnology Gateway

Center for Food Safety and Applied Nutrition(CFSAN) - Biotechnology - FDA Policy for new biotech plant varieties, consultation procedure and completed consultation (list of biotech plants).

Center for Biologics Evaluation and Research (CBER)

Docket No. 96M-0311 , CBER 38. PHS Guideline on Infectious Disease Issues in Xenotransplantation. Pages 8120 -8121 [FR Doc. 01-02125]
January 29, 2001 | html | | pdf |

• The Guidance

Docket No. 00N-0989, CBER 9863. Availability for Public Disclosure and Submission to FDA for Public Disclosure of Certain Data and Information Related to Human Gene Therapy or Xenotransplantation. Pages 4688-4706 [FR Doc. 01-1048] January 18, 2001 | html | | pdf |
Written comments by April 18, 2001
Written comments on information collection by February 20, 2001

CBER Guidances/Guidelines - contain links to relevant information on a variety of biotechnology topics

CBER Guidance for Industry: FDA Guidance for Human Somatic Cell Therapy and Gene Therapy , 1999

CBER Points to Consider in the Manufacture and Testing of Therapeutic Products for Human Use Derived from Transgenic Animals , 1995

Xenotransplantation

PHS Guideline on Infectious Disease Issues in Xenotransplantation
| html | | pdf | (January 19, 2001)

FDA Bioengineered Foods

Office of Science and Technology Policy (OSTP)

• Case Studies of Environmental Regulation for Biotechnology

• Science Division - Current Life Sciences Project