NME
Medical abbreviation · Medical Research
| Stands for | New molecular entity |
|---|---|
| Categories | Medical |
NME stands for New molecular entity, a medical research abbreviation.
Drug containing an active ingredient never before approved by the FDA in any form, as opposed to new formulations, combinations or uses of existing drugs. The yearly count of NME and new biologic approvals is a closely watched measure of pharmaceutical innovation.
Example: Of last year's novel approvals, most were NMEs and the rest new therapeutic biologics.
Usage notes
FDA's Center for Drug Evaluation and Research publishes an annual list of novel approvals. NMEs often receive five years of new chemical entity exclusivity. Biologic counterparts are new therapeutic biologics approved through biologics license applications.
Related abbreviations
More medical research abbreviations
- MA – Meta-analysis
- MedDRA – Medical Dictionary for Regulatory Activities
- MeSH – Medical Subject Headings
- MHRA – Medicines and Healthcare products Regulatory Agency
- NCT – National Clinical Trial (number)
- NICE – National Institute for Health and Care Excellence
- NNH – Number needed to harm
- NNT – Number needed to treat
- NPV – Negative predictive value
- NS – Not significant (statistically)
- ODD – Orphan drug designation
- OHRP – Office for Human Research Protections
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.