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FDA Finalizes CMC Guidance for Gene Therapy INDs

The FDA has issued its guidance for chemistry, manufacturing, and control information that is included in investigational new drug applications (INDs) for gene therapies, called "Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs)." The guidance finalizes the draft guidance that was released for comment in November 2004.

As the FDA explains in the introduction to the guidance, gene therapies present many manufacturing challenges. Some of these challenges include the variability and complexity inherent in the components used to generate the final product, such as ...

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