RPS Glossary

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Glossary of Abbreviations and Terms

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• 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