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- 20:26, 16 May 2011 diff hist +179 Regulated Product Submissions →Regulated Product Submission Release 3
- 20:25, 16 May 2011 diff hist +38 N File:201105 RPS Status Report - Joel Finkle FINAL.ppt RPS Status Report for May 2011 HL7 WGM current
- 15:17, 3 May 2011 diff hist +282 RPS R3 Glossary →60. keyword
- 15:08, 3 May 2011 diff hist +388 RPS R3 Glossary →19. component 1 – priority number
- 19:22, 20 April 2011 diff hist +204 RPS R3 Glossary →141. A Device Act Definition: Proposed SM definition
- 19:21, 20 April 2011 diff hist +341 RPS R3 Glossary →140. territorial authority
- 19:18, 20 April 2011 diff hist +119 RPS R3 Glossary →139. substance: Proposed SM definition
- 19:17, 20 April 2011 diff hist +162 RPS R3 Glossary →138. submission unit - status code: needs validation
- 19:16, 20 April 2011 diff hist +115 RPS R3 Glossary →138. submission unit - status code: Proposed SM definition
- 19:15, 20 April 2011 diff hist +95 RPS R3 Glossary →137. submission unit – title: Proposed SM definition
- 19:14, 20 April 2011 diff hist +324 RPS R3 Glossary →136. submission unit – code: Proposed SM definition - needs validation
- 19:13, 20 April 2011 diff hist +125 RPS R3 Glossary →135. submission unit – id: proposed def
- 19:12, 20 April 2011 diff hist +18 RPS R3 Glossary →134. submission unit
- 19:11, 20 April 2011 diff hist +488 RPS R3 Glossary →132. Submission unit: proposed def
- 19:08, 20 April 2011 diff hist +225 RPS R3 Glossary →131. submission reference: proposed def
- 19:04, 20 April 2011 diff hist +113 RPS R3 Glossary →130. submission group: proposed def
- 19:02, 20 April 2011 diff hist +9 RPS R3 Glossary →129. submission – value: What is this item used for?
- 18:59, 20 April 2011 diff hist +138 RPS R3 Glossary →128. submission – effective time: Proposed Def -- needs validation
- 18:57, 20 April 2011 diff hist +142 RPS R3 Glossary →127. submission – status code: proposed def
- 18:55, 20 April 2011 diff hist +130 RPS R3 Glossary →126. submission - code
- 18:54, 20 April 2011 diff hist +159 RPS R3 Glossary →125. submission - id: Proposed Def
- 18:46, 20 April 2011 diff hist +23 RPS R3 Glossary →124. submission
- 18:45, 20 April 2011 diff hist +388 RPS R3 Glossary →122. Submission: proposed def
- 18:42, 20 April 2011 diff hist +109 RPS R3 Glossary →121. subject7: proposed def
- 18:41, 20 April 2011 diff hist +114 RPS R3 Glossary →120. subject 6: proposed def
- 18:40, 20 April 2011 diff hist +158 RPS R3 Glossary →119. subject5: proposed def
- 18:39, 20 April 2011 diff hist +116 RPS R3 Glossary →118. subject4: proposed def
- 18:38, 20 April 2011 diff hist +110 RPS R3 Glossary →117. subject3: proposed def
- 18:37, 20 April 2011 diff hist +363 RPS R3 Glossary →116. subject2
- 18:35, 20 April 2011 diff hist +101 RPS R3 Glossary →115. subject1: proposed def
- 18:27, 20 April 2011 diff hist +176 RPS R3 Glossary →113. sequel to 2: Proposed Def
- 18:26, 20 April 2011 diff hist +322 RPS R3 Glossary →112. sequel to 1: Proposed Def
- 18:22, 20 April 2011 diff hist +128 RPS R3 Glossary →111. reviewable unit – status code: Proposed def
- 18:20, 20 April 2011 diff hist +264 RPS R3 Glossary →110. reviewable unit – code: proposed def
- 18:19, 20 April 2011 diff hist +105 RPS R3 Glossary →109. reviewable unit - id
- 18:17, 20 April 2011 diff hist -35 RPS R3 Glossary →108. reviewable unit: revised proposed definition
- 18:15, 20 April 2011 diff hist +140 RPS R3 Glossary →107. review procedure - code
- 18:14, 20 April 2011 diff hist +293 RPS R3 Glossary →106. review procedure
- 18:07, 20 April 2011 diff hist +185 RPS R3 Glossary →105. review choice: Proposed Def
- 18:02, 20 April 2011 diff hist +131 RPS R3 Glossary →104. review – effective time: Proposed def
- 16:04, 20 April 2011 diff hist +170 RPS R3 Glossary →103. review - status code: proposed def
- 16:02, 20 April 2011 diff hist +84 RPS R3 Glossary →102. review - id: proposed def
- 16:00, 20 April 2011 diff hist +379 RPS R3 Glossary →101. review: proposed def
- 15:57, 20 April 2011 diff hist +142 RPS R3 Glossary →100. replacement of: Proposed def
- 15:50, 20 April 2011 diff hist +119 RPS R3 Glossary →98. related Document - id: proposed def
- 15:45, 20 April 2011 diff hist +231 RPS R3 Glossary →96. related context of use – version number
- 15:38, 20 April 2011 diff hist +118 RPS R3 Glossary →95. related context of use - id: proposed def
- 15:36, 20 April 2011 diff hist +966 RPS R3 Glossary →94. related context of use: Proposed def, answered question.
- 19:32, 19 April 2011 diff hist +112 RPS R3 Glossary →93. reference3: Proposed def
- 19:18, 19 April 2011 diff hist +155 RPS R3 Glossary →92. reference2: Proposed def
- 19:14, 19 April 2011 diff hist +166 RPS R3 Glossary →91. reference1: Proposed Def
- 19:12, 19 April 2011 diff hist +149 RPS R3 Glossary →90. product category: Proposed def
- 18:49, 19 April 2011 diff hist +186 RPS R3 Glossary →89. product: Proposed def
- 18:46, 19 April 2011 diff hist +172 RPS R3 Glossary →88. primary information recipient: Added proposed def
- 16:57, 19 April 2011 diff hist +98 RPS R3 Glossary →77. organization
- 16:57, 19 April 2011 diff hist +185 RPS R3 Glossary →78. person: added definition
- 16:54, 19 April 2011 diff hist +430 RPS R3 Glossary →77. organization: Added a definition
- 16:50, 19 April 2011 diff hist +341 RPS R3 Glossary →74. links
- 16:31, 19 April 2011 diff hist +146 RPS R3 Glossary →57. information recipient
- 16:28, 19 April 2011 diff hist +181 RPS R3 Glossary →56. holder: Original is not readable
- 16:25, 19 April 2011 diff hist +241 RPS R3 Glossary →54. file
- 16:15, 19 April 2011 diff hist +97 RPS R3 Glossary →40. Document: added the two types of document
- 16:10, 19 April 2011 diff hist +29 RPS R3 Glossary →24. context of use: added mention of keywords. Do we also need to mention the "filter" objects for submissions and territories, or are their own definitions sufficient?
- 16:06, 19 April 2011 diff hist +83 RPS R3 Glossary →20. component2: Added definition, in addition to relationship.
- 15:54, 19 April 2011 diff hist +110 RPS R3 Glossary →18. component1: Added definition - I disagree that the CoU definition is sufficient.
- 15:47, 19 April 2011 diff hist +67 RPS R3 Glossary →21. component3: provided definition instead of just exception
- 20:50, 11 April 2011 diff hist +177 RPS R3 Glossary →15. choice
- 20:47, 11 April 2011 diff hist +36 RPS R3 Glossary →14. category event
- 20:46, 11 April 2011 diff hist +159 RPS R3 Glossary →13. call back contact
- 20:43, 11 April 2011 diff hist -13 m RPS R3 Glossary →11. author
- 20:43, 11 April 2011 diff hist +89 RPS R3 Glossary →12. authority
- 20:41, 11 April 2011 diff hist -6 RPS R3 Glossary →11. author
- 20:39, 11 April 2011 diff hist +208 RPS R3 Glossary →11. author
- 20:32, 11 April 2011 diff hist +65 RPS R3 Glossary →10. application reference - reason code
- 20:31, 11 April 2011 diff hist +171 RPS R3 Glossary →8. application reference
- 20:23, 11 April 2011 diff hist +9 RPS R3 Glossary
- 20:18, 11 April 2011 diff hist +142 RPS R3 Glossary changed structure to use Wiki headlines for easier editing of sections
- 20:16, 11 April 2011 diff hist -282 RPS R3 Glossary
- 20:09, 11 April 2011 diff hist +2 m RPS R3 Glossary
- 20:08, 11 April 2011 diff hist -3 m RPS R3 Glossary
- 22:00, 1 April 2011 diff hist +444 N Talk:RPS R3 Glossary Created page with "--~~~~ There is a question on the page as to whether the Application needs a Status element. Personally, I don't think so: It's the individual Submissions that are approved, with..." current
- 21:54, 1 April 2011 diff hist +783 RPS R3 Glossary Added Application ID, Application Code
- 21:43, 1 April 2011 diff hist +189 RPS R3 Glossary Updated the Application note (2.9)
- 21:31, 29 March 2011 diff hist +236 RPS R3 Glossary Applicant proposed definition
- 21:28, 29 March 2011 diff hist +236 RPS R3 Glossary Agent proposed definnition
- 19:23, 31 March 2010 diff hist +1 RPS Ontology current
- 19:23, 31 March 2010 diff hist +26 RPS Ontology
- 19:22, 31 March 2010 diff hist 0 N File:RPSOntology.zip current
- 19:20, 31 March 2010 diff hist +167 N RPS Ontology New page: This page is reserved for information about RPS Ontologies and controlled vocabularies. The file listed below is a stub, and does not have any content as of 4/1/2010.
- 17:32, 28 January 2010 diff hist +253 Regulated Activity Structure Hierarchy current
- 17:29, 28 January 2010 diff hist +20 N File:RASH Proposal Overview.pdf RASH Proposal slides current
- 17:24, 28 January 2010 diff hist +55 Regulated Activity Structure Hierarchy
- 17:21, 28 January 2010 diff hist +31 N File:RASH Project Scope Statement 20091214.doc RASH Scope Statement (proposed) current
- 17:20, 28 January 2010 diff hist +458 N Regulated Activity Structure Hierarchy New page: The Regulated Activity Structure Hierarchy (RASH) is a proposed structured document format to accompany Regulated Product Submissions (RPS). It is designed to be a ''machine-readable i...
- 17:18, 28 January 2010 diff hist +62 Regulated Clinical Research Information Management →RCRIM Projects
- 15:28, 4 January 2010 diff hist +173 m Regulated Product Submissions →1. Project Information
- 02:28, 16 December 2009 diff hist +1 m RPS Hyperlinking →RPS Hyperlinking current
- 02:25, 16 December 2009 diff hist +1,667 N RPS Hyperlinking New page: == RPS Hyperlinking == Hyperlinking between documents in electronic submissions is done wihin PDF (Portable Document Format) documents. RPS release 1 and 2 do not propose any changes to t...
- 02:10, 16 December 2009 diff hist +93 RPS Glossary →Glossary of Abbreviations and Terms
- 02:01, 16 December 2009 diff hist +931 N RPS Threaded Discussions New page: This would entail providing the ability to keep track of individual questions or issues, and the responses and comments from all interest parties. Example – and this may be more detail ...
- 02:01, 16 December 2009 diff hist +104 Regulated Product Submissions →Future Scope Discussions Topics
- 13:18, 4 December 2009 diff hist +227 Regulated Product Submissions →7.RPS Resources
- 12:59, 4 December 2009 diff hist 0 m Regulated Product Submissions →7.RPS Resources
- 12:58, 4 December 2009 diff hist -6 Regulated Product Submissions →7.RPS Resources
- 12:58, 4 December 2009 diff hist +88 Regulated Product Submissions Added resource links to R1 information
- 12:55, 4 December 2009 diff hist +477 Regulated Product Submissions
- 12:37, 15 September 2009 diff hist +59 m RPS Structure and Linking Discussion →Example Implementations
- 12:36, 15 September 2009 diff hist +1,241 RPS Structure and Linking Discussion →Hyperlinking
- 18:43, 19 August 2009 diff hist +547 RPS Master Files
- 22:33, 16 July 2009 diff hist +1,751 N RPS Structure and Linking Discussion Discussion of hyperlinking and file/folder structure
- 22:23, 16 July 2009 diff hist +1 m RPS R2 Project →Domain Analysis Links
- 22:23, 16 July 2009 diff hist +213 RPS R2 Project →Domain Analysis Links
- 16:40, 27 January 2009 diff hist +1 m RPS Glossary →Glossary of Abbreviations and Terms
- 16:43, 31 December 2008 diff hist +88 Common Product Model →Storyboards
- 16:37, 31 December 2008 diff hist +34 Common Product Model →Ambitions & Scope
- 22:41, 10 November 2008 diff hist +449 Document (RPS) →Additional Regional Definitions and Synonyms current
- 22:34, 10 November 2008 diff hist +1 m Context of Use (RPS) →R1 Working Definition current
- 22:33, 10 November 2008 diff hist +17 Context of Use (RPS) →Additional Regional Definitions and Synonyms
- 22:31, 10 November 2008 diff hist +248 Reviewable Unit (RPS) →Human Pharmaceuticals current
- 22:30, 10 November 2008 diff hist +78 Submission Unit (RPS) →Human Pharmaceuticals current
- 22:30, 10 November 2008 diff hist -164 Submission Unit (RPS) →Japan
- 22:25, 10 November 2008 diff hist +183 Submission (RPS) →Europe
- 22:24, 10 November 2008 diff hist +217 Application (RPS) →Human Pharmaceuticals
- 14:21, 28 October 2008 diff hist -1 Reviewable Unit (RPS)
- 14:21, 28 October 2008 diff hist -74 Submission Unit (RPS)
- 14:20, 28 October 2008 diff hist -114 Submission (RPS) Removed Japanese Device Definitions
- 14:20, 28 October 2008 diff hist -60 Application (RPS) Removed Japanese Device Definitions
- 16:40, 20 October 2008 diff hist 0 Submission Unit (RPS) →Human Pharmaceuticals)
- 16:39, 20 October 2008 diff hist +587 Submission Unit (RPS) →Additional Regional Definitions and Synonyms
- 16:08, 20 October 2008 diff hist +1,607 RPS Glossary/doc →Creating New Definition Pages current
- 16:02, 20 October 2008 diff hist +106 Reviewable Unit (RPS)
- 15:57, 20 October 2008 diff hist +1,497 Submission (RPS) →Additional Regional Definitions and Synonyms
- 15:48, 20 October 2008 diff hist +164 Submission (RPS) →R1 Working Definition: - updated to match terminology map more closely
- 15:41, 20 October 2008 diff hist +1,128 Application (RPS) →Additional Regional Definitions and Synonyms
- 20:14, 14 October 2008 diff hist +1,628 N Keyword (RPS) New page: This is a Glossary page ''This page is under discussion and definitions and aligmnent with the BRIDG model have not yet been finalized'' ==R1 Working Definition== A '''Keyword''' is a pi... current
- 20:04, 14 October 2008 diff hist +666 N File (RPS) New page: This is a Glossary page ''This page is under discussion and definitions and aligmnent with the BRIDG model have not yet been finalized'' ==R1 Working Definition== A single electronic fil... current
- 19:56, 14 October 2008 diff hist +1,853 N Context of Use (RPS) new definition
- 19:46, 14 October 2008 diff hist +21 RPS Glossary →Glossary of Abbreviations and Terms
- 14:21, 14 October 2008 diff hist -201 m Regulated Product Submission Release 2 (RPS R2) Storyboards →Example 2: Send Submission Unit to Regulated Industry
- 14:21, 14 October 2008 diff hist -217 Regulated Product Submission Release 2 (RPS R2) Storyboards →E.1 Additional Information about a Submission Unit: - moved Submission Unit Type and Contact Type definitions to RPS Glossary
- 14:12, 14 October 2008 diff hist +61 N Package (RPS) Redirecting to Submission Unit (RPS) current
- 14:11, 14 October 2008 diff hist +720 N Submission Unit Type (RPS) New page: This is a Glossary page ''This page is under discussion and definitions and aligmnent with the BRIDG model have not yet been finalized'' ==R1 Working Definition== The type of [[Submissio... current
- 14:09, 14 October 2008 diff hist +14 RPS Glossary →Glossary of Abbreviations and Terms
- 14:08, 14 October 2008 diff hist +93 RPS Glossary →Glossary of Abbreviations and Terms
- 14:06, 14 October 2008 diff hist +60 Contact Type (RPS) →R1 Working Definition current
- 14:05, 14 October 2008 diff hist +588 N Contact Type (RPS) New Definition
- 14:00, 14 October 2008 diff hist +90 RPS Glossary added two new definitions
- 14:10, 7 October 2008 diff hist +41 m Regulated Product Submission Release 2 (RPS R2) Storyboards
- 14:07, 7 October 2008 diff hist +232 Regulated Product Submission Release 2 (RPS R2) Storyboards Added links to glossary, removed definitions from this page.
- 14:03, 7 October 2008 diff hist +428 N Correspondence (RPS) New page: This is a Glossary page ''This page is under discussion and definitions and aligmnent with the BRIDG model have not yet been finalized'' ==R1 Working Definition== Any exchange of informa... current
- 13:57, 7 October 2008 diff hist +24 RPS Glossary →Glossary of Abbreviations and Terms
- 15:29, 1 October 2008 diff hist +272 Regulatory Authority (RPS) →R1 Working Definition current
- 15:26, 1 October 2008 diff hist +7 Regulatory Authority (RPS) →R1 Working Definition
- 15:24, 1 October 2008 diff hist +148 RPS Glossary →Glossary of Abbreviations and Terms
- 15:22, 1 October 2008 diff hist +56 N Regulatory Activity Redirecting to Submission (RPS) current
- 15:22, 1 October 2008 diff hist +57 N Dossier Redirecting to Application (RPS) current
- 15:21, 1 October 2008 diff hist +180 Application (RPS) →R1 Working Definition
- 15:18, 1 October 2008 diff hist 0 m Submission (RPS) →R1 Working Definition
- 15:18, 1 October 2008 diff hist +8 Submission (RPS) →R1 Working Definition
- 15:16, 1 October 2008 diff hist +4 Document (RPS) →Additional Regional Definitions and Synonyms
- 15:15, 1 October 2008 diff hist +363 Document (RPS) →Additional Regional Definitions and Synonyms
- 01:14, 30 September 2008 diff hist +59 RPS Glossary/doc →Abbreviations
- 01:13, 30 September 2008 diff hist 0 SNDA Redirecting to Supplemental New Drug Application current
- 01:11, 30 September 2008 diff hist +56 N DMF Redirecting to Drug Master File current
- 18:42, 29 September 2008 diff hist +72 N ANDA Redirecting to Abbreviated New Drug Application current
- 20:29, 26 September 2008 diff hist +4 NDA Redirecting to New Drug Application current
- 20:25, 26 September 2008 diff hist +56 N NDA New page: #REDIRECT:New Drug Application {{Category:RPS Glossary}}
- 15:18, 24 September 2008 diff hist +220 N Template:Documentation/docname New page: {{#switch: {{SUBPAGENAME}} |sandbox|testcases={{ #rel2abs: ../doc }} |#default={{SUBJECTPAGENAME}}/doc }}<noinclude> {{PAGENAME}} [[ja:Template:Docu... current
- 15:17, 24 September 2008 diff hist +674 N Template:Tlx New page: <includeonly><span style="font-family:monospace;"><nowiki>{{</nowiki>[[{{{LANG|}}}{{{SISTER|}}}{{ns:Template}}:{{{1|}}}|{{{1|}}}]]<!-- -->{{#if:{{{2|}}}| |{{{2}}} }}<!-- -->{{#if:{{{3... current
- 15:16, 24 September 2008 diff hist +1,112 N Template:Namespace detect New page: {{#switch: {{lc: <!--Lower case the result--> <!--If no or empty "demospace" parameter then detect namespace--> {{#if:{{{demospace|}}} | {{{demospace}}} | ... current
- 15:16, 24 September 2008 diff hist +624 N Template:Mbox New page: {{ {{namespace detect | demospace = {{{demospace|}}} | main = ambox | talk = tmbox | image = imbox | category = cmbox | other = ombox }} | type = ... current
- 15:15, 24 September 2008 diff hist +5,464 N Template:Pp-meta New page: {{#ifeq:{{lc:{{{small|}}}}}|yes| <div class="metadata plainlinks" id="protected-icon" style="position:absolute; z-index:100; right:55px; top:10px;"> {{#tag:imagemap| Image:{{{image|{{#swit... current
- 15:15, 24 September 2008 diff hist +2,784 N Template:Documentation New page: <div class="template-documentation"><!-- These are the literal class definitions in common.css: →For template documentation: .template-documentation { clear: both; margin: 1... current
- 15:14, 24 September 2008 diff hist +1,129 N Template:Pp-template New page: <includeonly>{{pp-meta |type=indef |small={{{small|}}} |demospace={{{demospace|}}} |expiry=<!--not applicable--> |dispute=no |icon-text=This {{#ifeq:{{NAMESPACE}}|{{ns:6}}|image, included ... current
- 15:14, 24 September 2008 diff hist +2,165 N Template:Ambox New page: <table class="metadata plainlinks ambox {{#switch:{{{type|}}} | speedy = ambox-speedy | serious <!-- This value is **deprecated**, please don't use it! --> | delete = ambox-del... current
- 15:13, 24 September 2008 diff hist +1,777 N Template:Expand-section/doc New page: {{documentation subpage}} ==Usage== Places article in Category:Articles to be expanded or in a dated category like [[:Category:Articles to be expanded since {{CURRENTMONTHNAME}} {{CUR... current
- 15:12, 24 September 2008 diff hist +1,288 N Template:Expand-section New page: <!-- {{expand-section}} start -->{{ambox |type=notice |image=36px |text = '''Please help [{{fullurl:{{FULLPAGENAME}}|action=edit}} improve this section] by expa... current
- 16:40, 23 September 2008 diff hist +2 International Conference on Harmonisation →Definition
- 16:39, 23 September 2008 diff hist +1,462 N International Conference on Harmonisation New page: This is a Glossary page ''This page is under discussion and definitions and aligmnent with the BRIDG model have not yet been finalized'' ==Definition== The '''International Conference on...
- 16:35, 23 September 2008 diff hist +57 RPS Glossary
- 16:32, 23 September 2008 diff hist +68 RPS Glossary →Glossary of Abbreviations and Terms
- 16:30, 23 September 2008 diff hist +159 Regulated Product Submission Release 2 (RPS R2) Business Scenario Development →Submission Activities: - added links to glossary as example
- 16:26, 23 September 2008 diff hist +183 Submission Unit (RPS) →R1 Working Definition
- 16:04, 23 September 2008 diff hist +22 Sponsor (RPS) current
- 16:03, 23 September 2008 diff hist +373 Sponsor (RPS)
- 15:01, 23 September 2008 diff hist +67 N EMEA Redirecting to European Medicines Agency current
- 15:00, 23 September 2008 diff hist +79 N MHLW Redirecting to Ministry of Health, Labor and Welfare current
- 14:59, 23 September 2008 diff hist +26 Food and Drug Administration
- 14:57, 23 September 2008 diff hist +55 N International Conference on Harmonization Redirecting to International Conference on Harmonisation current
- 14:56, 23 September 2008 diff hist +83 N ICH Redirecting to International Conference on Harmonisation current
- 14:54, 23 September 2008 diff hist +1 m Glossary
- 14:52, 23 September 2008 diff hist +132 Glossary
- 14:31, 23 September 2008 diff hist +29 CDRH Redirecting to Food and Drug Administration#Center for Devices and Radiological Health current
- 14:30, 23 September 2008 diff hist +111 Application current
- 12:11, 23 September 2008 diff hist +130 Document (RPS) A document can be multiple files, per Joe Cippolina
- 22:14, 22 September 2008 diff hist -28 Food and Drug Administration
- 22:10, 22 September 2008 diff hist +64 Food and Drug Administration
- 22:05, 22 September 2008 diff hist +780 Food and Drug Administration
- 21:53, 22 September 2008 diff hist +722 Food and Drug Administration
- 21:43, 22 September 2008 diff hist +113 N CFSAN Redirecting to Food and Drug Administration#Center for Food Safety and Applied Nutrition current
- 21:43, 22 September 2008 diff hist +9 Food and Drug Administration →Center for Food Safety and Nutrition (CFSAN)
- 21:42, 22 September 2008 diff hist +68 N FDA Redirecting to Food and Drug Administration current
- 21:42, 22 September 2008 diff hist +113 N Center for Food Safety and Applied Nutrition Redirecting to Food and Drug Administration#Center for Food Safety and Applied Nutrition current
- 21:37, 22 September 2008 diff hist +839 Food and Drug Administration
- 21:28, 22 September 2008 diff hist +82 N CDRH Redirecting to Center for Devices and Radiological Health
- 21:26, 22 September 2008 diff hist +60 N Food and Drug Administration New page: ==Center for Devices and Radiological Health (CDRH)== {stub]
- 21:25, 22 September 2008 diff hist +110 N Center for Devices and Radiological Health Redirecting to Food and Drug Administration#Center for Devices and Radiological Health current
- 20:22, 19 September 2008 diff hist +48 Document Reference (RPS) current
- 20:21, 19 September 2008 diff hist +10 Document (RPS)
- 20:20, 19 September 2008 diff hist +9 Reviewable Unit (RPS)
- 20:19, 19 September 2008 diff hist 0 Submission Unit (RPS)
- 20:17, 19 September 2008 diff hist +9 Submission Unit (RPS)
- 20:16, 19 September 2008 diff hist +5 Submission (RPS)
- 20:14, 19 September 2008 diff hist -5 Application (RPS) →Additional Regional Definitions and Synonyms
- 20:14, 19 September 2008 diff hist +1 Application (RPS) →Additional Regional Definitions and Synonyms
- 20:14, 19 September 2008 diff hist +13 m Application (RPS)
- 20:13, 19 September 2008 diff hist -2 m Application (RPS) →R1 Working Definition
- 19:55, 19 September 2008 diff hist +27 RPS Glossary →Glossary of Abbreviations and Terms
- 19:53, 19 September 2008 diff hist +90 RPS Glossary →Glossary of Abbreviations and Terms
- 19:49, 19 September 2008 diff hist +701 RPS Glossary/doc
- 19:43, 19 September 2008 diff hist -5 RPS Glossary/doc →Creating New Definition Pages
- 19:41, 19 September 2008 diff hist +1,197 N RPS Glossary/doc New page: ==Creating New Definition Pages== Pages listed in Red on the glossary page do not yet exist. Clicking on them will create a new page with a Wikipedia editing window. Copy the following wi...
- 19:27, 19 September 2008 diff hist +122 RPS Glossary
- 19:16, 19 September 2008 diff hist +235 N Talk:Document Reference (RPS) New page: --~~~~ Question: Is this meant to be the Relationship, such as the old eCTD "operation"? Or is this the referencing of materials outside of the current application or submission? current
- 19:15, 19 September 2008 diff hist +597 N Document Reference (RPS) New page: This is a Glossary page ''This page is under discussion and definitions and aligmnent with the BRIDG model have not yet been finalized'' ==R1 Working Definition== Provides a reference to...
- 19:12, 19 September 2008 diff hist +2 m Regulatory Authority (RPS) →R1 Working Definition
- 19:11, 19 September 2008 diff hist +853 N Regulatory Authority (RPS) New page: This is a Glossary page ''This page is under discussion and definitions and aligmnent with the BRIDG model have not yet been finalized'' ==R1 Working Definition== Governmental bodies tha...
- 19:07, 19 September 2008 diff hist +255 RPS Glossary →Glossary of Abbreviations and Terms
- 19:00, 19 September 2008 diff hist +218 N Talk:Sponsor (RPS) New page: --~~~~ - "Drug or Device" was replaced in the working definition with "Regulated Product." I can't believe the RPS definition was ever limited to drug or device. current
- 18:59, 19 September 2008 diff hist +909 N Sponsor (RPS) New page: This is a Glossary page ''This page is under discussion and definitions and aligmnent with the BRIDG model have not yet been finalized'' ==R1 Working Definition== An organization that as...
- 18:44, 19 September 2008 diff hist +454 N Regulated Product (RPS) New page: This is a Glossary page ''This page is under discussion and definitions and aligmnent with the BRIDG model have not yet been finalized'' ==R1 Working Definition== TBD as [[Product (RPS)|... current
- 18:42, 19 September 2008 diff hist +56 Product (RPS) →R1 Working Definition current
- 18:40, 19 September 2008 diff hist +1,245 N Product (RPS) New page: This is a Glossary page ''This page is under discussion and definitions and aligmnent with the BRIDG model have not yet been finalized'' ==R1 Working Definition== TBD. Definition may be ...
- 18:35, 19 September 2008 diff hist +7 Application (RPS) →R1 Working Definition
- 18:32, 19 September 2008 diff hist +38 Application (RPS) →R1 Working Definition
- 17:22, 19 September 2008 diff hist +52 Application (RPS)
- 17:20, 19 September 2008 diff hist +63 Submission (RPS) Definition of Submission
- 17:19, 19 September 2008 diff hist +1 Reviewable Unit (RPS)
- 17:19, 19 September 2008 diff hist +114 Reviewable Unit (RPS)
- 17:18, 19 September 2008 diff hist +51 Reviewable Unit (RPS) Definition of Reviewable Unit
- 17:17, 19 September 2008 diff hist 0 m Submission Unit (RPS)
- 17:16, 19 September 2008 diff hist 0 Submission Unit (RPS) Definition of RPS Submission Unit
- 17:16, 19 September 2008 diff hist +51 m Submission Unit (RPS) Definition of RPS Submission Unit
- 17:13, 19 September 2008 diff hist 0 m Submission Unit (RPS)
- 17:12, 19 September 2008 diff hist +6 Document Relationship (RPS) current
- 17:11, 19 September 2008 diff hist +6 m Document (RPS)
- 17:11, 19 September 2008 diff hist +7 m Submission Unit (RPS)
- 17:10, 19 September 2008 diff hist +2 m Document Relationship (RPS)
- 17:09, 19 September 2008 diff hist +1 m Document (RPS)
- 17:09, 19 September 2008 diff hist +1 m Document (RPS)
- 17:09, 19 September 2008 diff hist +1 Document (RPS)
- 17:08, 19 September 2008 diff hist +49 Document (RPS) Definition of RPS Document
- 17:07, 19 September 2008 diff hist +802 N Document Relationship (RPS) Definition of RPS Document Relationship
- 16:57, 19 September 2008 diff hist +141 Document (RPS) →R1 Working Definition
- 16:55, 19 September 2008 diff hist +162 N Talk:Document (RPS) New page: --~~~~ - I added to this definition to link to Context of Use, Document Relationship and Submission Unit. current