Company will supply additional quality control information "about one of the methods to be used to release Thyrogen," Genzyme said following the receipt of an "approvable" letter from FDA Sept. 15. Thyrogen (thyrotropin alpha for injection) was recommended for imaging of thyroid cancer "as a substitute for withdrawal depending upon clinical circumstances" by FDA's Endocrinologic & Metabolic Drugs Advisory Committee May 15 ("The Pink Sheet" May 18, p. 7) . FDA asked Genzyme to submit a plan that includes an acceptable timeline and protocol refining the requirement used to determine the bioactivity of a reference standard and for release specifications of the final product
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