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The CMC chasm. Why most biotech IND submissions fail at chemistry, not biology.

Year: 2026

Type: article

Abstract: Explains why the Chemistry, Manufacturing, and Controls section is a frequent cause of IND clinical holds. Describes what CMC covers under 21 CFR 312.23(a)(7) and how sponsors should build it as a program rather than paperwork.

Source: Zenodo (CERN European Organization for Nuclear Research)

DOI: 10.5281/zenodo.23352278

Author: Hillman, Andrew Jonathan

Language: English

Topic: Biomedical Ethics and Regulation

Subfield: Physiology

Field: Medicine

Domain: Health Sciences

Open Access status: green

OpenAlex ID: W7221672916

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