Become a partner

registreringsansökan för biologisk medicinsk produkt (FDA-term) (BLA)

Biologics License Application [ENGLISH]

Request to the US Food and Drug Administration (FDA) for permission to distribute, including for purposes of sale or clinical application, a biologic medicinal product across states in the USA.

registreringsansökan för biologisk medicinsk produkt (FDA-term) [SWEDISH]

Registreringsansökan för bilologisk medicinsk produkt (FDA-term).


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

Feedback and comments on the word description