Erratum: Trends in breakthrough therapy designation
نویسندگان
چکیده
منابع مشابه
Developing standards for breakthrough therapy designation in oncology.
In July 2012, Congress passed the Food and Drug Administration Safety and Innovation Act (FDASIA). The Advancing Breakthrough Therapies for Patients Act was incorporated into a Title of FDASIA to expedite clinical development of new, potential "breakthrough" drugs or treatments that show dramatic responses in early-phase studies. Using this regulatory pathway, once a promising new drug candidat...
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Recent advances in biotechnology have led to discoveries resulting in major improvements in the therapy of refractory malignancies, although most advanced cancers remain incurable. Thus, there is global consensus around the need to streamline the drug approval process for effective agents. Accelerated Approval and Breakthrough Therapy Designation hold the promise of making new treatments availa...
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Author details Orphan Medicines Office, European Medicines Agency, 7 Westferry Circus, Canary Wharf, London E144HB, UK. Bundesinstitut für Arzneimittel und Medizinprodukte, Kurt-Georg-Kiesinger-Allee 3, Bonn 53175, Germany. Läkemedelsverket, Dag Hammarskjölds vägen 42, Uppsala 75103, Sweden. Research Institute for Medicines (iMED.ULisboa), Faculty of Pharmacy, University of Lisbon, Lisboa 1649-...
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ژورنال
عنوان ژورنال: Nature Reviews Drug Discovery
سال: 2016
ISSN: 1474-1776,1474-1784
DOI: 10.1038/nrd.2016.43