From the Porcine to the Ridiculous: Veterinary Drugmaker Sues FDA for Alleged APA Violations
FDA Law Blog: Biosimilars
JANUARY 18, 2024
The company asserts that carbadox residues fall below dangerous levels before the products hit consumers’ plates, and that the Agency’s anti-carbadox bias and failure to follow the mandated regulatory procedures violated the “the FDCA, FDA’s regulations, the APA, and due process.” Carbadox has had a tortured approval history.
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