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What is already known about this subject Applications for extension of indications are currently more frequent than new drug applications within cancer drugs. There is a notable lack of knowledge of potential differences in the review process of applications for extensions of indications between the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA).
What is already known about this subject A rapid progress in the development of advanced therapy medicinal products (ATMPs) has taken place over the past decades. The ATMPs hold great potential but face challenges in the clinical development and the regulatory process. What this study adds Our findings showed substantial variation between regulatory agencies in the number of ATMPs with marketing authorization.
Abstract Background: An Achilles tendon rupture (ATR) is a frequent injury and results in the activation of tendon cells and collagen expression, but it is unknown to what extent turnover of the tendon matrix is altered before or after a rupture. Purpose/Hypothesis: The purpose of this study was to characterize tendon tissue turnover before and immediately after an acute rupture in patients.
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