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Table of Contents
Biotechnology
Regulatory Overview
Animal Feeds and Plants
Animal Drugs & Animals
Related Links
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University of Maryland
AgNIC Agricultural Biotechnology Gateway
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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).
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Center for Biologics Evaluation and Research (CBER)
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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
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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
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Written comments by April 18, 2001
Written comments on information collection by February
20, 2001
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CBER Guidances/Guidelines
- contain links to relevant information on a variety of
biotechnology topics
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CBER
Guidance for Industry: FDA Guidance for Human Somatic Cell
Therapy and Gene Therapy , 1999
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CBER Points to Consider in the Manufacture and Testing
of Therapeutic Products for Human Use Derived from Transgenic
Animals , 1995
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Xenotransplantation
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PHS Guideline on Infectious Disease Issues in Xenotransplantation
| html
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| (January 19, 2001)
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FDA
Bioengineered Foods
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Office of Science and Technology
Policy (OSTP)
Web page updated by mdt,
November 7, 2003, 1:10 PM ET
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