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dc.contributor.authorBrown, Christopher Matthew
dc.date.accessioned2014-03-04T18:55:21Z
dc.date.available2014-03-04T18:55:21Z
dc.date.issued2010-08
dc.identifier.otherbrown_christopher_m_201008_ms
dc.identifier.urihttp://purl.galileo.usg.edu/uga_etd/brown_christopher_m_201008_ms
dc.identifier.urihttp://hdl.handle.net/10724/26581
dc.description.abstractDue to the extremely wide range of medical products being governed by the same few sets of general regulations, the FDA has created a system of documents to guide and direct manufacturers on how to apply those regulations to specific types of products. How those documents are used and how effective they are at providing adequate guidance was determined through a series of phone interviews with FDA and medical products industry personnel. In general, the guidance document system works well for both the industry and the FDA. However, some improvement is desired in the process for creating and revising guidance documents due to the long, multiple-stage process currently in place.
dc.languageeng
dc.publisheruga
dc.rightspublic
dc.subjectFDA
dc.subjectGuidance
dc.subjectGuidance document
dc.subjectMedical products industry
dc.subjectRegulations
dc.subjectGood guidance practices
dc.subjectGGP
dc.titleHow has the FDA's and the medical products industry's use of guidance documents evolved over the years and how will the use of guidance documents continue to evolve in the future?
dc.typeThesis
dc.description.degreeMS
dc.description.departmentBioPharma Regulatory Affairs
dc.description.majorPharmacy
dc.description.advisorGary Dykstra
dc.description.committeeGary Dykstra
dc.description.committeeRandall Tackett
dc.description.committeeDavid Mullis
dc.description.committeePaul Brooks
dc.description.committeeRonald Arkin


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