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Guideline on the Requirements for the Submission of Chemistry, Manufacturing, and Control (CMC) Information for Cell-based Clinical Trial Applications
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Guideline addresses the specific documentation requirements for evaluation of Chemistry, Manufacturing, and Control Information parts in Investigational New Drug Applications (INDs) submitted to the Saudi Food and Drug Authority. The requirements are sourced from the FDA and EMA guidelines.
06/10/2022 - 05/12/2022
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Last Modified Date: 06/10/2022 - 12:08 PM Saudi Arabia Time