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Monday, September 08, 2008

FDA/USDA Guidance for Industry on Plant-Made Pharmaceuticals Regulations

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The FDA/USDA made its "Guidance for Industry: Drugs, Biologics, and Medical Devices Derived from Bioengineered Plants for Use in Humans and Animals" available for open public comment. This open comment period, which closed Feb. 7, allowed for the submission of comments of FDA/USDA regulations concerning plant-made pharmaceuticals from the public as a whole.

Draft Guidance for Industry (PDF)
Comments submitted by patient advocacy groups:

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