The authors review the current regulatory framework for the selection of drug substance starting materials. The term starting material has been adopted to indicate the point where regulatory change ...

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 ...

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 ...

Any UAB employee shipping, handling, or offering for transport samples considered Biological Substances, Category B Genetically Modified Organisms (GMOs), Exempt Human or Animals Specimens (EPS)must ...