| Abbreviations & Acronyms: |
| BLA - biologics license application |
| BPM - business process management |
| CAPA - corrective and preventive action |
| CBT - computer based training |
| CFR - Code of Federal Regulations |
| cGMP - current good manufacturing process |
| CIOMS - Council for International Organizations of Medical Sciences |
| CME - continuing medical education |
| CQA - clinical quality assurance |
| CRA - clinical research associate |
| CRF - case report form |
| CRO - contract research organization |
| CTMS - clinical trial management system |
| DDMAC - Divison of Drug Marketing, Advertising and Communications |
| DOJ - Department of Justice |
| DTC - direct to consumer |
| DTP - direct to patient |
| eCTD - electronic common technical document |
| ED - erectile dysfunction |
| EMEA - European Medicines Agency |
| EU - European Union |
| FDA - Food and Drug Administration |
| FDA3 - Food and Drug Administration Amendments Act |
| FDAAA - Food and Drug Administration Amendments Act |
| GCP - good clinical practice |
| GLP - good laboratory practice |
| GMP- good manufacturing practice |
| GxP - good x practice |
| HCP - health care professional |
| HME - home medical equipment |
| HRx - HR-human resources; Rx-prescription |
| ICH - International Conference on Harmonization |
| IND - investigational new drug |
| IRB - institutional review board |
| IVRS - interactice voice response system |
| IWRS - interactive web response system |
| KOL - key opinion leader |
| MDUFA - Medical Device User Fee Amendments |
| MHRA - Medicines and Healthcare Product Regulatory Agency (United Kingdom) |
| MSL - medical science liason |
| NDA - new drug application |
| OIG - Office of Inspector General |
| OTC - over the counter |
| PAI - pre-approval inspection |
| PAP - patient assistance program |
| PMA - pre-market approval |
| PMDA - Pharmaceutical and Medical Devices Agency (Japan) |
| QA - quality assurance |
| RFP - request for proposal |
| RNAi - ribonucleic acid interference |
| Rx - prescription |
| SOP - standard operating procedure |
| SOX - Sarbanes-Oxley |
| SPL - structured product labeling |
| WOM - word of mouth |
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