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BIO Comments on Established Conditions Reportable CMC Changes

<p>
The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the &ldquo;Draft Guidance on Established Conditions: Reportable CMC Changes for Approved Drug and Biologic Products&rdquo; (&ldquo;Draft Guidance&rdquo;).</p>

The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the “Draft Guidance on Established Conditions: Reportable CMC Changes for Approved Drug and Biologic Products” (“Draft Guidance”).

Generally, BIO would like to highlight the following three points:
  1. The Draft Guidance is one positive step forward on reporting chemistry, manufacturing, and controls (CMC) changes for approved drug and biologic products;
  2. Many changes to an approved drug and biologic product can be managed by the Pharmaceutical Quality System (PQS); and
  3. We encourage FDA to work with the International Conference on Harmonization (ICH), specifically the Q12 working group, on a global approach for these types of changes.