Difference between revisions of "RPS Glossary"

From HL7Wiki
Jump to navigation Jump to search
Line 2: Line 2:
 
== Glossary of Abbreviations and Terms ==
 
== Glossary of Abbreviations and Terms ==
 
''This article is under construction''
 
''This article is under construction''
*Abbreviated New Drug Application (ANDA)
+
*[[Abbreviated New Drug Application]] (ANDA)
*Annotated ECG (aECG)
+
*[[Annotated ECG]] (aECG)
 
*[[Application (RPS)|Application]]
 
*[[Application (RPS)|Application]]
*Application Number  
+
*[[Application Number]]
*Board of Health (BoH)
+
*[[Approval (RPS)|Approval]]
*Chemistry, Manufacturing and Controls (CMC)
+
*[[Approval Unit (RPS)|Approval Unit]]
*Center for Devices and Radiological Health (CDRH) (FDA)
+
*[[Board of Health]] (BoH)
*Center for Food Safety and Applied Nutrition (CFSAN) (FDA)
+
*[[Chemistry, Manufacturing and Controls]] (CMC)
*Context of Use
+
*[[Center for Devices and Radiological Health]] (CDRH) (FDA)
 +
*[[Center for Food Safety and Applied Nutrition]] (CFSAN) (FDA)
 +
*[[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)
+
*[[Drug Master File]] (DMF)
*Electrocardiogram (ECG)
+
*[[Electrocardiogram]] (ECG)
*European Union (EU)
+
*[[European Union]] (EU)
*external electronic source / non-retrievable
+
*[[External Electronic Source (RPS)|External Electronic Source]] / non-retrievable
*Food and Drug Administration (FDA) (US)
+
*[[Food and Drug Administration]] (FDA) (US)
*Holder of Reference Master File
+
*[[Holder of Reference Master File]]
*Investigational New Drug (IND)
+
*[[Investigational New Drug]] (IND)
*Investigator Brochure (IB)
+
*[[Investigator Brochure]] (IB)
*Keyword
+
*[[Keyword (RPS)|Keyword]]
*Master Access File
+
*[[Master Access File]]
*Master File Holder
+
*[[Master File Holder]]
*Member State
+
*[[Member State]]
*New Drug Application (NDA)
+
*[[New Drug Application]] (NDA)
*Periodic Safety Update Report (PSUR)
+
*[[Periodic Safety Update Report]] (PSUR)
*Phase I Meeting
+
*[[Phase I Meeting]]
*Phase II Meeting
+
*[[Phase II Meeting]]
*Post-market
+
*[[Post-market]]
*Pre-submission
+
*[[Pre-submission]]
 
*[[Regulated Product (RPS)|Regulated Product]]
 
*[[Regulated Product (RPS)|Regulated Product]]
 
*[[Regulated Product Submission]] (RPS)
 
*[[Regulated Product Submission]] (RPS)
 
*[[Regulatory Authority (RPS)|Regulatory Authority]]
 
*[[Regulatory Authority (RPS)|Regulatory Authority]]
 
*[[Reviewable Unit (RPS)|Reviewable Unit]]
 
*[[Reviewable Unit (RPS)|Reviewable Unit]]
*Right of Reference Request
+
*[[Right of Reference Request]]
 
*[[Submission (RPS)|Submission]]
 
*[[Submission (RPS)|Submission]]
 
*[[Submission Unit (RPS)|Submission Unit]]
 
*[[Submission Unit (RPS)|Submission Unit]]
 
*[[Sponsor (RPS)|Sponsor]]
 
*[[Sponsor (RPS)|Sponsor]]
*Supplemental New Drug Application (sNDA)
+
*[[Supplemental New Drug Application]] (sNDA)
*Table of Contents (TOC)
+
*[[Table of Contents]] (TOC)
*Threaded Discussion
+
*[[Threaded Discussion]]

Revision as of 19:07, 19 September 2008