OTAT Town Hall on Cell Therapy CMC – The Recording is Available but Here’s an Appetizer
FDA Law Blog
JANUARY 4, 2023
The next town hall will focus on the clinical development of gene therapy products for rare diseases in February 2023. The Agency stated that the most common reason for a clinical hold of a Phase 1 study under an investigational new drug (IND) is related to safety. Common CMC Issues for Phase 1 IND Study. Comparability.
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