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| Line 4: | Line 4: | ||
*Abbreviated New Drug Application (ANDA) | *Abbreviated New Drug Application (ANDA) | ||
*Annotated ECG (aECG) | *Annotated ECG (aECG) | ||
| − | *[[RPS | + | *[[Application (RPS)|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 (RPS)|Document]] |
| − | *[[ | + | *[[Document Reference (RPS)|Document Reference]] |
| − | *[[ | + | *[[Document Relationship (RPS)|Document Relationship]] |
*Drug Master File (DMF) | *Drug Master File (DMF) | ||
*Electrocardiogram (ECG) | *Electrocardiogram (ECG) | ||
| Line 32: | Line 32: | ||
*Post-market | *Post-market | ||
*Pre-submission | *Pre-submission | ||
| − | *[[ | + | *[[Regulated Product (RPS)|Regulated Product]] |
*[[Regulated Product Submission]] (RPS) | *[[Regulated Product Submission]] (RPS) | ||
| − | *[[ | + | *[[Regulatory Authority (RPS)|Regulatory Authority]] |
| − | *[[ | + | *[[Reviewable Unit (RPS)|Reviewable Unit]] |
*Right of Reference Request | *Right of Reference Request | ||
| − | *[[RPS | + | *[[Submission (RPS)|Submission]] |
| − | *[[ | + | *[[Submission Unit (RPS)|Submission Unit]] |
| − | *[[RPS | + | *[[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 16:25, 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
