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BRIEF-SteadyMed receives refusal to file letter from FDA for Trevyent new drug application
2017年8月31日 / 上午10点58分 / 22 天前

BRIEF-SteadyMed receives refusal to file letter from FDA for Trevyent new drug application

Aug 31 (Reuters) - Steadymed Ltd

* SteadyMed Ltd - FDA determined that application is not sufficiently complete to permit a substantive review

* SteadyMed - ‍within next 30 days, will request a type a meeting with FDA for clarification on additional information required for resubmission​ of NDA

* SteadyMed - ‍FDA requested further information on certain device specifications and performance testing on final, to-be-marketed Trevyent product​

* SteadyMed ltd - FDA requested additional design verification and validation testing on final, to-be-marketed Trevyent product​ Source text for Eikon: Further company coverage:

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