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engineering or manufacturing variables or critical characteristics necessary to support regulatory agency policy and decision-making
The purpose of laboratory research is to collect data related to the development, quality assurance or control, product design, adaptive responses or induced cellular or molecular changes, mode of action, efficacy, safety, toxicological effects, safety assessments, etc.
for diagnostic, therapeutic or other novel, beneficial purposes
In addition, one area of scientific research, biomedical research, includes research involving humans, the purpose of which is to advance knowledge that may facilitate the development of safe and effective, useful products.
, clinical growth, early market availability or post-market tracking
An investigational product is any food, product, or medical or radiation-emitting product intended for human consumption that is subjected to ex vivo, biological, chemical, physical or microbiological or in vivo testing throughout its life cycle, such as preclinical development.
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