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BIO Comments on FDA Draft Guidance on Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products

March 22, 2018

BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance, Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products.

BIO supports the FDA’s efforts to update and replace the 1997 version of this guidance, and suggests the FDA revise the guidance entitled Changes to an Approved Application for Specified Biotechnology and Specified Synthetic Biological Products, which is also dated July 1997.

BIO appreciates the inclusion of cellular, gene, and cell-based gene therapy products in the scope but notes some of these products are excluded as exceptions in certain examples in the appendix. BIO’s comments include suggested changes to promote the longevity of the guidance, make terminology more consistent, and promote continuity and consistency across various guidelines.

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2018-03-22 BIO Comments On CMC Changes To Approved Application Certain Biological Products FINAL
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