Day

March 25, 2019
25
Mar

CBER Finalizes Standards Guidance

March 25, 2019
The US FDA Center for Biologics Evaluation and Research (CBER) finalized the December 2017 draft guidance titled “Standards Development and the Use of Standards in Regulatory Submissions Reviewed in the Center for Biologics Evaluation and Research” today.  The guidance makes clear that CBER recognizes the value and proper usage of standards and further encourages the...
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