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== Glossary of Abbreviations and Terms == | == Glossary of Abbreviations and Terms == | ||
| − | *[[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]] | ||
*[[Approval (RPS)|Approval]] | *[[Approval (RPS)|Approval]] | ||
*[[Approval Unit (RPS)|Approval Unit]] | *[[Approval Unit (RPS)|Approval Unit]] | ||
| − | *[[Board of Health]] (BoH) | + | *[[Board of Health]] ([[BoH]]) |
| − | *[[Chemistry, Manufacturing and Controls]] (CMC) | + | *[[Chemistry, Manufacturing and Controls]] ([[CMC]]) |
| − | *[[Center for Devices and Radiological Health]] (CDRH) (FDA) | + | *[[Center for Devices and Radiological Health]] ([[CDRH]]) (FDA) |
| − | *[[Center for Food Safety and Applied Nutrition]] (CFSAN) (FDA) | + | *[[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) | + | *[[Drug Master File]] ([[DMF]]) |
| − | *[[Electrocardiogram]] (ECG) | + | *[[Electrocardiogram]] ([[ECG]]) |
| − | *[[European Union]] (EU) | + | *[[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) | + | *[[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 (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) | + | *[[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]] | ||
| Line 46: | Line 46: | ||
*[[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 (RPS)|Threaded Discussion]] |
Revision as of 19:53, 19 September 2008
Main Page | Regulated Clinical Research Information Management | Regulated Product Submissions | RPS Glossary
This article is under construction
Please see the RPS Glossary Documentation page for instructions for creating and editing entries.
Glossary of Abbreviations and Terms
- Abbreviated New Drug Application (ANDA)
- Annotated ECG (aECG)
- Application
- Application Number
- Approval
- Approval Unit
- 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
