ProdiGene To Develop “Field Trial” Compliance Program Following Violation
Executive Summary
ProdiGene is working with FDA and USDA to develop a compliance program as part of a settlement agreement relating to safety violations in the production of plant-made pharmaceuticals
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BIO Wants Tighter Controls For Plant-Made Drugs, But No Fencing
More details should be required for a permit to grow biotechnology-derived crops, the Biotechnology Industry Organization says in comments on a joint FDA/Department of Agriculture draft guidance on plant-made pharmaceuticals
ProdiGene/USDA settlement
ProdiGene and Department of Agriculture reach settlement that includes a $250,000 fine and a commitment to additional inspections and employee training after ProdiGene's pharmaceutical-producing corn commingled with soybean crops (1"The Pink Sheet" Nov. 25, p. 24)...