New molecular entity

{
  "id": "MLC-T-CHM-007929",
  "term": "New molecular entity",
  "field": "Chemistry",
  "definition": "A drug substance containing no active moiety that has been approved by the Food and Drug Administration (FDA) previously either as a new drug or as an active ingredient in a drug product. It represents a molecule with a unique chemical structure that has not been marketed as an active pharmaceutical ingredient. The FDA assigns a New Molecular Entity designation to novel compounds during the drug approval process.",
  "subject": "Chemistry and Human Health",
  "see_also": [
    "new chemical entity"
  ],
  "references": [
    "PAC, 2013, 85, 1725. 'Glossary of terms used in medicinal chemistry. Part II (IUPAC Recommendations 2013)' on page 1743 (https://doi.org/10.1351/PAC-REC-12-11-23)"
  ],
  "url": "https://mlchart.com/terminology/chemistry/new-molecular-entity/"
}