Difference between revisions of "RPS Glossary"

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(New page: Main Page | Regulated Clinical Research Information Management | Regulated Product Submissions | RPS Glossary == Glossary of Abbreviations and Terms == ''This article is under ...)
 
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*Abbreviated New Drug Application (ANDA)
 
*Abbreviated New Drug Application (ANDA)
 
*Annotated ECG (aECG)
 
*Annotated ECG (aECG)
*Application
+
*[[RPS Application|Application]]
 
*Application Number  
 
*Application Number  
 
*Board of Health (BoH)
 
*Board of Health (BoH)
Line 11: Line 11:
 
*Center for Food Safety and Applied Nutrition (CFSAN) (FDA)
 
*Center for Food Safety and Applied Nutrition (CFSAN) (FDA)
 
*Context of Use
 
*Context of Use
 +
*[[RPS Document|Document]]
 +
*[[RPS Document Reference|Document Reference]]
 +
*[[RPS Document Relationship|Document Relationship]]
 
*Drug Master File (DMF)
 
*Drug Master File (DMF)
 
*Electrocardiogram (ECG)
 
*Electrocardiogram (ECG)
Line 29: Line 32:
 
*Post-market
 
*Post-market
 
*Pre-submission
 
*Pre-submission
 +
*[[RPS Regulated Product|Regulated Product]]
 
*[[Regulated Product Submission]] (RPS)
 
*[[Regulated Product Submission]] (RPS)
 +
*[[RPS Regulatory Authority|Regulatory Authority]]
 +
*[[RPS Reviewable Unit|Reviewable Unit]]
 
*Right of Reference Request
 
*Right of Reference Request
*Submission
+
*[[RPS Submission|Submission]]
*Submission Unit
+
*[[RPS Submission Unit|Submission Unit]]
 +
*[[RPS Sponsor|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 15:58, 19 September 2008

Main Page | Regulated Clinical Research Information Management | Regulated Product Submissions | RPS Glossary

Glossary of Abbreviations and Terms

This article is under construction

  • Abbreviated New Drug Application (ANDA)
  • Annotated ECG (aECG)
  • Application
  • Application Number
  • Board of Health (BoH)
  • Chemistry, Manufacturing and Controls (CMC)
  • Center for Devices and Radiological Health (CDRH) (FDA)
  • Center for Food Safety and Applied Nutrition (CFSAN) (FDA)
  • Context of Use
  • Document
  • Document Reference
  • Document Relationship
  • Drug Master File (DMF)
  • Electrocardiogram (ECG)
  • European Union (EU)
  • external electronic source / non-retrievable
  • Food and Drug Administration (FDA) (US)
  • Holder of Reference Master File
  • Investigational New Drug (IND)
  • Investigator Brochure (IB)
  • Keyword
  • Master Access File
  • Master File Holder
  • Member State
  • New Drug Application (NDA)
  • Periodic Safety Update Report (PSUR)
  • Phase I Meeting
  • Phase II Meeting
  • Post-market
  • Pre-submission
  • Regulated Product
  • Regulated Product Submission (RPS)
  • Regulatory Authority
  • Reviewable Unit
  • Right of Reference Request
  • Submission
  • Submission Unit
  • Sponsor
  • Supplemental New Drug Application (sNDA)
  • Table of Contents (TOC)
  • Threaded Discussion