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NDA (FDA specifik) (NDA)

New Drug Application (FDA specific) [ENGLISH]

Vehicle used to request approval from the US Food and Drug Administration (FDA) to sell or market a new pharmaceutical product in the USA.

NDA (FDA specifik) [SWEDISH]

Ansökan som används för att begära godkännande från US Food and Drug Administration (FDA) för att sälja eller marknadsföra en ny farmaceutisk produkt i USA.


Resources and references

Definitions have been translated into the Swedish language from the following sources:

  1. 1. American Society of Gene and Cell Therapy Glossary
  2. 2. Clinical Trials Information System
  3. 3. EMA Glossary of Regulatory Terms
  4. 4. EMA Medical Terms simplifier
  5. 5. Glossary of Terms used in EU Clinical Trials Register
  6. 6. Glossary of Terms U.S Food and Drug Administration
  7. 7. National Human Genome Research Institute “Talking Glossary of Genomic and Genetic Terms”
  8. 8. The Glossary for Advanced Therapies Regen. Med. Dec 2020 Vol. 15 No. 12 Suppl. 1
  9. 9. Toolkit For Patient Focused Therapy Development Glossary

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