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engineering or manufacturing variables or critical attributes that are needed to support the policies and decision-making of regulatory agencies
Laboratory research is intended to accumulate data related to development, quality assurance or control, product design, adaptive responses or induced cellular or molecular changes, mode of action, efficacy, safety, toxicological effects, safety assessments, and other issues.
In addition, one area of scientific research—biomedical research—includes human research
subjects whose purpose is to promote knowledge that may facilitate the development of safe and effective products that are useful for diagnostic, therapeutic, or other innovative, beneficial purposes.
, clinical growth, early market availability or post-launch monitoring
An investigational article is any food, product, medical, or radiation-emitting device intended for human use that is subjected to ex vivo, biological, chemical, physical, or microbiological testing or in vivo testing throughout the life cycle, such as in preclinical development.