Glossary of key terms, abbreviations, and concepts in pharmaceutical research and development.
| Term | Definition | Category |
|---|---|---|
| ORR | Objective Response Rate – The proportion of patients with tumor size reduction of a predefined amount. | Efficacy |
| NDA | New Drug Application – Submission to FDA for approval to market a new drug. | Regulatory |
| PDUFA | Prescription Drug User Fee Act – Law that allows FDA to collect fees from drug manufacturers to fund approval process. | Regulatory |
| AE | Adverse Event – Any undesirable experience associated with the use of a medical product. | Safety |
| BLA | Biologics License Application – Submission to FDA for approval to market a biologic product. | Regulatory |