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Pharmaceuticals / Regulatory Affairs

FDA Updates 1997 Guidance on CMC Changes for Approved Biologics

Dec. 27, 2017

The FDA is revising its 20-year-old guidance on the appropriate categorization of changes in chemistry, manufacturing and controls information in approved BLAs, based on a tiered reporting system.

The new draft guidance aims to reduce the burden for drugmakers when reporting changes, and to keep pace with advances in manufacturing and testing.

The agency reclassified the risks associated with specific changes, offering new recommendations for reporting categories as well as new examples. The FDA believes the update will help get products back into distribution faster following a change.

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