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avancerad terapi för regenerativ medicin (RMAT)

Regenerative Medicine Advanced Therapy [ENGLISH]

Designation awarded by the US Food and Drug Administration (FDA) that is intended to expedite the development and review of regenerative medicine therapies, such as cell therapies, tissue-based products and gene therapies, that meet an unmet medical need in a serious or life threatening indication and show promising preliminary clinical evidence.

avancerad terapi för regenerativ medicin [SWEDISH]

Beteckning tilldelad av US Food and Drug Administration (FDA) som är avsedd att påskynda utvecklingen och översynen av regenerativa medicinterapier, såsom cellterapier, vävnadsbaserade produkter och genterapier, som tillgodoser ett otillfredsställt medicinskt behov i ett allvarligt eller liv hotande indikation och visa lovande preliminära kliniska bevis.

2024-01-29

Search in ATMP dictionary

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 https://www.asgct.org/education/more-resources/glossary
  2. 2. Clinical Trials Information System https://www.ema.europa.eu/en/human-regulatory-overview/research-and-development/clinical-trials-human-medicines/clinical-trials-information-system
  3. 3. EMA Glossary of Regulatory Terms https://www.ema.europa.eu/en/about-us/glossaries/glossary-regulatory-terms
  4. 4. EMA Medical Terms simplifier https://www.ema.europa.eu/en/documents/other/ema-medical-terms-simplifier_en.pdf
  5. 5. Glossary of Terms used in EU Clinical Trials Register https://www.clinicaltrialsregister.eu/doc/EU_Clinical_Trials_Register_Glossary.pdf
  6. 6. Glossary of Terms U.S Food and Drug Administration https://www.fda.gov/patients/clinical-trials-what-patients-need-know/glossary-terms
  7. 7. National Human Genome Research Institute “Talking Glossary of Genomic and Genetic Terms” https://www.genome.gov/genetics-glossary/m#glossary
  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 https://toolkit.ncats.nih.gov/glossary-2/

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