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FDA issues guidelines for bioengineered plants

(Thursday, Sept. 12, 2002 -- CropChoice news) --

The FDA's Center for Biologics Evaluation and Research is seeking public comments within 120 days of the date of publication in the Federal Register, expected on September 12, on a draft document entitled "Guidance for Industry: Drugs, Biologics, and Medical From Bioengineered Plants for Use in Humans and Animals."

This document is intended to provide guidance to sponsors, manufacturers, licensees, and applicants of products derived from bioengineered plants or plant materials. An electronic copy of the draft, which was prepared in collaboration with USDA, is posted at

http://www.fda.gov/OHRMS/DOCKETS/98fr/02d-0324-gdl0001.pdf The FDA Sept. 11 Federal Register Prepublication notice is posted at http://www.fda.gov/OHRMS/DOCKETS/98fr/02d-0324-nad0001.pdf