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The EU CTA filings for CTX001 are also The FDA placed a clinical hold on the investigational new drug Application we filed clinical trial applications



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Lysogene Announces FDA approval of IND Application to

Posted on January 30, 2015 March 2, 2015 by China Drug Consulting. 1. Overview of Drug Administration in China. In general, Clinical Trial Application (CTA)

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National Drug Authority No person may carry out any clinical trial in respect of any drug unless he or she is in The clinical trial application (CTA)

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National Drug Authority No person may carry out any clinical trial in respect of any drug unless he or she is in The clinical trial application (CTA)

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Alnylam Pharmaceuticals, Inc. (ALNY - Free Report) announced that it has filed a Clinical Trial Authorization (CTA) application to Medicines and Healthcare products

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Initiative to Streamline Clinical Trials The Initiative to Streamline Clinical Trials areas of concern identified included Clinical Trial Applications, drug

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FibroGen Announces China FDA Approval of CTA to Conduct

Clinical Trials in the EU/EEA – Focus on CMC Aspects. defining the requirements for the conduct of clinical trials in the a Clinical Trial Application (CTA)

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Health Canada Approves Clinical Trial Application for Anti

Smoother Regulatory Process for China. For new drug applications that have already six months after submission for both the clinical trial application (CTA)

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FDA IND and UK MHRA CTA approval both achieved in H1 2018 ; Celixir announced in January the approval of a clinical trial application (CTA)

Cta clinical trial application fda - Introduction to the CTA & NDA process in China

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