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Joelfinkle (talk | contribs) (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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| Line 4: | Line 4: | ||
*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
