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Choice of timetable for type II variations and worksharing applications
Choice of timetable for type II variations and worksharing applications
Type-II variations: questions and answers | European Medicines Agency
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NAVIGATING THE EMA
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EMA Publishes New Timeline For DADI Project | EXTEDO
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Frontiers | Contribution of patient registries to regulatory decision making on rare diseases medicinal products in Europe
Frontiers | Paediatric Medicines in Europe: The Paediatric Regulation—Is It Time for Reform?
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NAVIGATING THE EMA
Optimizing Pediatric Medicine Developments in the European Union Through Pragmatic Approaches - Rei Bolislis - 2021 - Clinical Pharmacology & Therapeutics - Wiley Online Library
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Use of Real-world Data for New Drug Applications and Line Extensions - Clinical Therapeutics
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The impact of FDA and EMA regulatory decision-making process on the access to CFTR modulators for the treatment of cystic fibrosis | Orphanet Journal of Rare Diseases | Full Text
Use of Real-world Data for New Drug Applications and Line Extensions - Clinical Therapeutics
Q&A: Type II variations | European Medicines Agency