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Difference between revisions of "RPS Glossary"
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*[[Document Reference (RPS)|Document Reference]] | *[[Document Reference (RPS)|Document Reference]] | ||
*[[Document Relationship (RPS)|Document Relationship]] | *[[Document Relationship (RPS)|Document Relationship]] | ||
| + | *[[Dossier]] - Generalized synonym for RPS [[Application (RPS)|Application]] concept | ||
*[[Drug Master File]] ([[DMF]]) | *[[Drug Master File]] ([[DMF]]) | ||
*[[Electrocardiogram]] ([[ECG]]) | *[[Electrocardiogram]] ([[ECG]]) | ||
| Line 44: | Line 45: | ||
*[[Regulated Product (RPS)|Regulated Product]] | *[[Regulated Product (RPS)|Regulated Product]] | ||
*[[Regulated Product Submission]] (RPS) | *[[Regulated Product Submission]] (RPS) | ||
| − | *[[Regulatory Activity]] | + | *[[Regulatory Activity]] -- Generalized synonym for RPS [[Submission (RPS)|Submission]] |
*[[Regulatory Authority (RPS)|Regulatory Authority]] | *[[Regulatory Authority (RPS)|Regulatory Authority]] | ||
*[[Reviewable Unit (RPS)|Reviewable Unit]] | *[[Reviewable Unit (RPS)|Reviewable Unit]] | ||
Revision as of 15:24, 1 October 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
- Correspondence
- Document
- Document Reference
- Document Relationship
- Dossier - Generalized synonym for RPS Application concept
- 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
- International Conference on Harmonisation (ICH)
- Investigational New Drug (IND)
- Investigator Brochure (IB)
- Keyword
- Master Access File
- Master File Holder
- Member State
- Message
- New Drug Application (NDA)
- Periodic Safety Update Report (PSUR)
- Phase I Meeting
- Phase II Meeting
- Post-market
- Pre-submission
- Product
- Regulated Product
- Regulated Product Submission (RPS)
- Regulatory Activity -- Generalized synonym for RPS Submission
- Regulatory Authority
- Reviewable Unit
- Right of Reference Request
- Sponsor
- Submission
- Submission Unit
- Supplemental New Drug Application (sNDA)
- Table of Contents (TOC)
- Threaded Discussion
