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2007-01-05 | permalink
SemBioSys to proceed with abbreviated regulatory path for plant-produced insulin after meeting with the FDA
SemBioSys Genetics Inc. (TSX:SBS), a biotechnology company developing a broad pipeline of protein-based pharmaceuticals and non-pharmaceutical products, today provided an update on the expected regulatory strategy for the Company’s plant-produced insulin after a recent meeting with the U.S. Food and Drug Administration (FDA). The preparatory meeting for the Company’s Investigational New Drug Application (IND) for plant-produced insulin was scheduled as part of the normal development process. SemBioSys approached the FDA to confirm the viability of submitting plant-produced insulin under Section 505(b)(2) of the Food, Drug, and Cosmetic Act in order to achieve approval for a New Drug Application.
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2007-01-05 | permalink
SemBioSys to proceed with abbreviated regulatory path for plant-produced insulin after meeting with the FDA
SemBioSys Genetics Inc. (TSX:SBS), a biotechnology company developing a broad pipeline of protein-based pharmaceuticals and non-pharmaceutical products, today provided an update on the expected regulatory strategy for the Company’s plant-produced insulin after a recent meeting with the U.S. Food and Drug Administration (FDA). The preparatory meeting for the Company’s Investigational New Drug Application (IND) for plant-produced insulin was scheduled as part of the normal development process. SemBioSys approached the FDA to confirm the viability of submitting plant-produced insulin under Section 505(b)(2) of the Food, Drug, and Cosmetic Act in order to achieve approval for a New Drug Application.
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