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Clarification Sought for Continuous Manufacturing Guidance
05/15/2019
 

Janssen says it recognizes and appreciates FDA efforts to issue a draft guidance related to quality considerations for continuous manufacturing. In a comment letter, the company says it supports the draft guidance content and believes that once it is finalized, all stakeholders will receive significant benefits.

The letter lists several topics on which it seeks further explanation/clarification: post-approval regulatory submissions, run-time extension, active process controls, and entire batch rejection. It also includes specific line-by-line comments.


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