Difference between revisions of "RPS Glossary"

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== Glossary of Abbreviations and Terms ==
 
== Glossary of Abbreviations and Terms ==
*[[Abbreviated New Drug Application]] (ANDA)
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*[[Abbreviated New Drug Application]] ([[ANDA]])
*[[Annotated ECG]] (aECG)
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*[[Annotated ECG]] ([[aECG]])
 
*[[Application (RPS)|Application]]
 
*[[Application (RPS)|Application]]
 
*[[Application Number]]
 
*[[Application Number]]
 
*[[Approval (RPS)|Approval]]
 
*[[Approval (RPS)|Approval]]
 
*[[Approval Unit (RPS)|Approval Unit]]
 
*[[Approval Unit (RPS)|Approval Unit]]
*[[Board of Health]] (BoH)
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*[[Board of Health]] ([[BoH]])
*[[Chemistry, Manufacturing and Controls]] (CMC)
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*[[Chemistry, Manufacturing and Controls]] ([[CMC]])
*[[Center for Devices and Radiological Health]] (CDRH) (FDA)
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*[[Center for Devices and Radiological Health]] ([[CDRH]]) (FDA)
*[[Center for Food Safety and Applied Nutrition]] (CFSAN) (FDA)
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*[[Center for Food Safety and Applied Nutrition]] ([[CFSAN]]) (FDA)
 
*[[Context of Use (RPS)|Context of Use]]
 
*[[Context of Use (RPS)|Context of Use]]
 
*[[Document (RPS)|Document]]
 
*[[Document (RPS)|Document]]
 
*[[Document Reference (RPS)|Document Reference]]
 
*[[Document Reference (RPS)|Document Reference]]
 
*[[Document Relationship (RPS)|Document Relationship]]
 
*[[Document Relationship (RPS)|Document Relationship]]
*[[Drug Master File]] (DMF)
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*[[Drug Master File]] ([[DMF]])
*[[Electrocardiogram]] (ECG)
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*[[Electrocardiogram]] ([[ECG]])
*[[European Union]] (EU)
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*[[European Union]] ([[EU]])
 
*[[External Electronic Source (RPS)|External Electronic Source]] / non-retrievable
 
*[[External Electronic Source (RPS)|External Electronic Source]] / non-retrievable
*[[Food and Drug Administration]] (FDA) (US)
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*[[Food and Drug Administration]] ([[FDA]]) (US)
 
*[[Holder of Reference Master File]]
 
*[[Holder of Reference Master File]]
*[[Investigational New Drug]] (IND)
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*[[Investigational New Drug]] ([[IND]])
*[[Investigator Brochure]] (IB)
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*[[Investigator Brochure]] ([[IB]])
 
*[[Keyword (RPS)|Keyword]]
 
*[[Keyword (RPS)|Keyword]]
 
*[[Master Access File]]
 
*[[Master Access File]]
 
*[[Master File Holder]]
 
*[[Master File Holder]]
 
*[[Member State]]
 
*[[Member State]]
*[[New Drug Application]] (NDA)
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*[[New Drug Application]] ([[NDA]])
*[[Periodic Safety Update Report]] (PSUR)
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*[[Periodic Safety Update Report]] ([[PSUR]])
 
*[[Phase I Meeting]]
 
*[[Phase I Meeting]]
 
*[[Phase II Meeting]]
 
*[[Phase II Meeting]]
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*[[Submission Unit (RPS)|Submission Unit]]
 
*[[Submission Unit (RPS)|Submission Unit]]
 
*[[Sponsor (RPS)|Sponsor]]
 
*[[Sponsor (RPS)|Sponsor]]
*[[Supplemental New Drug Application]] (sNDA)
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*[[Supplemental New Drug Application]] ([[sNDA]])
*[[Table of Contents]] (TOC)
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*[[Table of Contents]] ([[TOC]])
*[[Threaded Discussion]]
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*[[Threaded Discussion (RPS)|Threaded Discussion]]

Revision as of 19:53, 19 September 2008