面对全球抗菌耐药性(AMR)的威胁,EMA发布了关于新抗生素评估的最终修订指南。In accordance with an agreement with the U.S. FDA and Japan’s Pharmaceuticals and Medical Devices Agency, the EMA’s guideline aligns as much as possible with the data requirements of those regulators so drug developers can design clinical trials that meet the evidence needs of all three agencies, the EMA said.
美国FDA在放置深脑刺激(DBS)设备治疗帕金森氏病之前已收到有关使用神经心理学测试的公民请愿书。请愿人的大多数名称已被编辑,他说没有为此目的进行标准化测试,因此,患者应自行决定评估自己的测试的含义或不应看到使用这些测试的使用。question of whether to go ahead with placement of a DBS device for Parkinson’s.