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engineering or manufacturing variables or critical attributes needed to support regulatory agency policy and decision making

The objective of laboratory research is to accumulate data to address issues related to development, quality assurance or control, product design, adaptive responses or induced cellular or molecular changes, mode of action, efficacy, safety, toxic effects, safety evaluations, and others.

the development of safe and effective products useful for diagnostic, therapeutic or other innovative, beneficial purposes

A test article is any food, product or medical or radiation-emitting product intended for human use that is subject to ex vivo, biological, chemical, physical or microbiological testing or an in vivo life cycle study, such as would be preclinical development.

, clinical growth, early market availability or post-market surveillance

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