Regulatory Considerations in Drug and Device Development: The Process and the Science - PowerPoint PPT Presentation

Regulatory Considerations in Drug and Device Development: The Process and the Science

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2. Introduction. Background on U.S. Food and Drug Administration (FDA)mission, goals, and short historycurrent structure of FDAProcess of drug developmentdefinitions of common termsphases of drug developmentProcess of device development. 3. The Scientific Method. Roger Bacon, monk, philosopher and alchemistDescribed scientific method in 13th centuryRepeating cycle of:ObservationHypothesisExperimentationVerification/replicationRegulations are based on GOOD SCIENCENot

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Regulatory Considerations in Drug and Device Development: The Process and the Science

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