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US FDA Expects Updates On Investigational Gene Therapy CMC Improvements

 
• By Bowman Cox

Final gene therapy IND CMC guidance clarifies expectations on process evolution, distinguishing drug substances from products, cGMP oversight and more.

Hand inserts a molecule into DNA concept design.
fda's final advice on cmc for investigational gene therapies

The US Food and Drug Administration repeatedly emphasized in the final version of its guidance on chemistry, manufacturing and control information for investigational gene therapies its expectation that sponsors will continually improve manufacturing processes and analytics during development – and that they will update their investigational new drug applications (INDs) accordingly.

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Gene Therapy Sponsor INTERACT, Pre-IND Meeting Confusion Lingers Despite FDA Guidance

 
• By Sue Sutter

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Ascertaining the novelty and benefits of Makary’s new drug approval idea – along with what it would take to implement it – requires more clarity on the types of studies he envisions being used to grant and confirm “plausible mechanism’ approvals.

EU Pharmacopoeia Adopts ‘Groundbreaking’ Cell Therapy Chapter, Seeks Feedback On Alternative Microbiological Tests

 
• By Neena Brizmohun

A new chapter that will be published in the European Pharmacopoeia soon is expected to provide a comprehensive framework for the production and quality control of cell-based preparations. Meanwhile, an existing chapter has been revised to facilitate the implementation of rapid microbiological testing methods.

India Signals ‘Systemic Changes’ In CGT Regulatory Approach

 
• By Anju Ghangurde

India is pressing ahead with “big shifts” in its regulatory approach for cell and gene therapies. Reduced “layers of review”, tighter internal timelines, upcoming guidelines to facilitate CGT development and reforms in the constitution of expert committees are some of the key changes.

More from Advanced Technologies

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• By Bridget Silverman

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• By Lisa Takagi

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