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FDA Biologics (BLA & Biosimilars)
Original article

OTAT Town Hall: Gene Therapy Chemistry, Manufacturing, and Controls - 09/29/2022

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Summary

The FDA's Office of Tissues and Advanced Therapies (OTAT) is hosting a virtual town hall to address stakeholder questions on gene therapy chemistry, manufacturing, and controls as the first in a series of informational events.

Importance:2/10
Sentiment:
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Gene TherapyChemistry Manufacturing ControlsFDARegulatory GuidanceStakeholder Engagement
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Published by FDA Biologics (BLA & Biosimilars) on September 9, 2026 6:48 PM

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