Food and Drug Administration. April 2009 – Federal Register Recent Federal Regulation Documents
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Propylthiouracyl (PTU)-Related Liver Toxicity; Public Workshop
The Food and Drug Administration (FDA) is announcing a 1-day public workshop, cosponsored with the American Thyroid Association (ATA), entitled ``Propylthiouracyl (PTU)-Related Liver Toxicity.'' This public workshop is intended to provide a public forum for discussion of the clinical, scientific, and regulatory issues pertaining to PTU- induced hepatitis to seek constructive input from academia, regulatory scientists, and other interested parties on the topic of PTU-induced hepatitis. The input from this public workshop will help the ATA to develop guidelines for the management of hyperthyroidism and help inform FDA about necessary changes to prescription drug labeling for PTU.