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RPS Glossary
Revision as of 19:27, 19 September 2008 by Joelfinkle (talk | contribs)
Main Page | Regulated Clinical Research Information Management | Regulated Product Submissions | RPS Glossary
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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
