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== Glossary of Abbreviations and Terms == | == Glossary of Abbreviations and Terms == | ||
''This article is under construction'' | ''This article is under construction'' | ||
| − | *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]] |
| − | *Board of Health (BoH) | + | *[[Approval (RPS)|Approval]] |
| − | *Chemistry, Manufacturing and Controls (CMC) | + | *[[Approval Unit (RPS)|Approval Unit]] |
| − | *Center for Devices and Radiological Health (CDRH) (FDA) | + | *[[Board of Health]] (BoH) |
| − | *Center for Food Safety and Applied Nutrition (CFSAN) (FDA) | + | *[[Chemistry, Manufacturing and Controls]] (CMC) |
| − | *Context of Use | + | *[[Center for Devices and Radiological Health]] (CDRH) (FDA) |
| + | *[[Center for Food Safety and Applied Nutrition]] (CFSAN) (FDA) | ||
| + | *[[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 |
| − | *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 | + | *[[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]] |
| − | *Post-market | + | *[[Post-market]] |
| − | *Pre-submission | + | *[[Pre-submission]] |
*[[Regulated Product (RPS)|Regulated Product]] | *[[Regulated Product (RPS)|Regulated Product]] | ||
*[[Regulated Product Submission]] (RPS) | *[[Regulated Product Submission]] (RPS) | ||
*[[Regulatory Authority (RPS)|Regulatory Authority]] | *[[Regulatory Authority (RPS)|Regulatory Authority]] | ||
*[[Reviewable Unit (RPS)|Reviewable Unit]] | *[[Reviewable Unit (RPS)|Reviewable Unit]] | ||
| − | *Right of Reference Request | + | *[[Right of Reference Request]] |
*[[Submission (RPS)|Submission]] | *[[Submission (RPS)|Submission]] | ||
*[[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]] |
Revision as of 19:07, 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
- 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
