Food and Drug Administration (FDA), the UK Medicines and Healthcare products Regulatory Agency (MHRA) and the European Medicines Agency (EMA), regarding the trial design. * References: https://covariants.org/per-country ...
Based on the human clinical experience with ARCT-021 we initiated the present accelerated, integrated phase 1/2/3a/3b study, designed following EMA, FDA and WHO guidance, to evaluate the safety, reactogenicity, immunogenicity, and efficacy of ARCT-154. We present the first study results up ...
4月28日,美国FDA发布警告,提醒医疗系统注意植入美敦力心室辅助装置Heartware(HVAD)的患者,出现泵内血栓的HVAD可能存在泵内焊接缺陷,从而导致血泵故障。 近日,国家心血管病中心在北京召开会议,宣布正式成立“国家心血管病专家委员会心血管代...