Regulatory Aspects of Chemistry Manufacturing and Controls for Investigational New Drug Applications and Biologic License Applications to the United States Food and Drug Administration

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Figure 1. Pyramid of regulatory documents.

There is a bewildering array of information on the regulatory requirements for submitting an application to the Food and Drug Administration (FDA) from the FDA website, industry journal articles, webinars, and conferences. This article highlights critical aspects of the regulatory requirements for the Chemistry, Manufacturing, and Controls (CMC) section for Investigational New Drug (IND) applications and Biologic License Applications (BLAs). This article will draw attention to key regulations, guidance documents, and white papers. By no means is this article comprehensive; however, it will provide a global overview of the regulatory process from Phase 1 through Licensure.

2011, Pages 439–452

Volume 3: Industrial Biotechnology and Commodity Products