Resources for Food and Drug Administration (FDA)

FDA Panel Gives Blessing to First Drug Manufactured in Bioengineered Goats

www.xconomy.com

The first drug ever manufactured in genetically-modified animals is likely coming soon to the U.S. market. A panel of expert advisers to the FDA said today that an experimental anti-clotting product developed by Framingham, MA-based GTC Biotherapeutics looks safe and effective enough to become a marketed product.The advisers essentially agreed with the conclusions reached by FDA staff, based on documents that were made publicly available Wednesday morning. The FDA still hasn’t made a final decision; its deadline for doing so is Feb. 7.

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