This article was originally published in SRA
EMEA wants early dialogue with developers of nanomedicinal products
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The Trump administration says a COVID-19 vaccine could be available in as little as 12 months, but most experts think that is overpromising unless safety or efficacy standards are sacrificed. Many are urging pivotal studies that look at clinical outcomes, not surrogates, for US FDA approval.
When asked about an inspector general report that found hospitals are struggling with tests and resources, and are looking to the federal government to help facilitate more efficient distribution of medical devices to fight the COVID-19 crisis, President Trump attacked the report as a political hit from an Obama holdover.
Japanese medical device manufacturer Terumo Corp. promoted senior management execs; MiMedx Group, developer of human placental tissue allografts, raised exec to CFO; and more.