Material Substance is a column, penned by Christopher Brenny and presented by ArchDaily Materials, which investigates the innovative applications of materials in architecture. On a purely aesthetic ...
The author provides a review of FDA's guidance document, Guidance for Industry: Q11 Development and Manufacture of Drug Substances, and its relation to the International Conference on Harmonization's ...
The author describes how providing appropriate information about the API in the Common Technical Document can aid FDA's review of an abbreviated new drug application. The generic drug market has ...
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