New Drug Applications

FDA Issues Complete Response Letter for PDP-716 NDA Due to Inspection Findings at Third-Party API Manufacturing Facility

Written by David Miller

No issues with clinical efficacy or safety were identified in the CRL No additional clinical data or trials have been requested Mumbai, India, July 13, 2023 – Sun Pharma Advanced Research Company Ltd. (Reuters: SPRC.BO, Bloomberg: SPADV IN,…Original Article

About the author

David Miller

a pharmacist, a tech enthusiastic, who explored the Internet to gather all latest information pharma, biotech, healthcare and other related industries.

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