BTD
Medical abbreviation · Medical Research
| Stands for | Breakthrough therapy designation |
|---|---|
| Categories | Medical |
BTD stands for Breakthrough therapy designation, a medical research abbreviation.
FDA designation for drugs intended to treat serious conditions when preliminary clinical evidence suggests substantial improvement over available therapy on a clinically significant endpoint. It brings intensive FDA guidance, senior management involvement and eligibility for rolling and priority review.
Example: BTD granted after phase 1 response rates far exceeded standard therapy.
Usage notes
Created by the FDA Safety and Innovation Act of 2012. It is one of several expedited programs, along with fast track, accelerated approval and priority review. Designation does not change the standards for approval.
Related abbreviations
More medical research abbreviations
- 510(k) – Premarket notification (FDA section 510(k))
- AHRQ – Agency for Healthcare Research and Quality
- ARR – Absolute risk reduction
- AUC – Area under the receiver operating characteristic curve
- CBER – Center for Biologics Evaluation and Research
- CDER – Center for Drug Evaluation and Research
- CEA – Cost-effectiveness analysis
- CI – Confidence interval
- CITI – Collaborative Institutional Training Initiative
- COI – Conflict of interest
- CONSORT – Consolidated Standards of Reporting Trials
- CPG – Clinical practice guideline
See all 94 medical research abbreviations →
This entry is for general education and is not medical advice. Abbreviation use varies between institutions; always confirm in context.