Medscape
The top US regulator of medicines this week said he wants to officially approve an animal-derived thyroid drug, seemingly addressing concerns sparked by a press release from his own agency.
On August 6, the FDA sent letters to manufacturers , importers, and distributors of animal-derived thyroid medications, stating that the agency “intends to take action against marketed unapproved animal-derived thyroid (ADT) products (sometimes described as desiccated thyroid extract [DTE] products).”
“Due to their complex biological origin, these medications contain many compounds that are uncharacterized for safety and effectiveness,” the FDA said, noting that it could take as long as “12 months to safely transition patients to an FDA-approved thyroid hormone replacement product.”
“FDA is not tak
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