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Sie suchen in allen Bereichen nach dem Autor Gonzalez S.
In der Rubrik Zeitschriften haben wir 2 Beiträge für Sie gefunden
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MerkenFDA' s “Breakthrough“ Drug Therapy Designation
Rubrik: Arzneimittelwesen
(Treffer aus pharmind, Nr. 07, Seite 958 (2015))
FDA' s “Breakthrough“ Drug Therapy Designation / A real regulatory breakthrough for innovations? Part 2*Part 1 see Pharm. Ind. 77, Nr. 6, 801–808 (2015). · Gonzalez S, Hofer J · 1EUDRAC GmbH, Heidelberg und 2EXDRA GmbH, Grafing bei München
Following the establishment of FT, PR and AA in the Unites States of America, similar approaches have been adopted in the European Union (EU) to accelerate patient access to novel therapies for serious diseases. The programs introduced in the EU compromise accelerated assessment, conditional approval and approval under exceptional circumstances. The accelerated assessment may be requested for “ medicinal products for human use which are of major interest from the point of view of public health and in particular from the viewpoint of therapeutic innovation ” [ 22 ]. What accounts for a ‘major public health interest' is not defined. ...
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Silvia Stephanie Gonzalez
MerkenFDA' s “Breakthrough“ Drug Therapy Designation
Rubrik: Arzneimittelwesen
(Treffer aus pharmind, Nr. 06, Seite 801 (2015))
FDA' s “Breakthrough“ Drug Therapy Designation / A real regulatory breakthrough for innovations? Part 1 · Gonzalez S, Hofer J · 1EUDRAC GmbH, Heidelberg und 2EXDRA GmbH, Grafing bei München
Accelerated Approval Adaptive Licensing Biologics License Application Breakthrough Therapy Center for Biologics Evaluation and Research Center for Drug Evaluation and Research Committee for Medicinal Products for Human Use European Commission European Medicines Agency End of Phase 2 Elements to Assure Safe Use European Union Food and Drug Administration Food and Drug Administration Modernization Act Food and Drug Administration Safety and Innovation Act Food, Drug and Cosmetic Act Fast Track International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Irreversible Morbidity or Mortality Investigational New Drug (Application) Not Applicable New Drug Application Prescription Drug User Fee ...
