RPS Glossary

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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
  • 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 Submission (RPS)
  • Right of Reference Request
  • Submission
  • Submission Unit
  • Supplemental New Drug Application (sNDA)
  • Table of Contents (TOC)
  • Threaded Discussion