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FDA Issues Complete Response Letter for TransCon PTH in Hypo
FDA Issues Complete Response Letter for TransCon PTH in Hypo
FDA Issues Complete Response Letter for TransCon PTH in Hypoparathyroidism
Announced on May 1, the CRL from the FDA expressed concerns related to manufacturing control strategy, but did not express concern related to clinical data submitted as part of the NDA package for TransCon PTH.
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