FDAnews Drug Daily Bulletin

FDA Releases Updated Guidance on Rules for CMC Changes

April 26, 2016

The FDA has a slate of new recommendations companies should follow when submitting a comparability protocol assessing changes to the chemistry, manufacturing or controls of a drug or biologic after the agency has approved its production process.

Foremost among the changes are new expectations for supporting materials that should accompany all applicable comparability protocols, including prior information justifying the production change; a summation of a risk assessment of the proposed change; data supporting the change derived from the product’s development and initial production process; research concerning the proposed change and its potential effects on product quality; and in the case of recombinant DNA-derived products, information supporting the relevance of the change.

Another change was the agency warning companies not to submit comparability protocols for changes in API suppliers or alterations that would affect a product’s approved labeling.


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