Gracie Sheng on Clubhouse

Bio

Gracie sheng, more than 20 years of pharmaceutical experience. in development, quality, and regulatory science. Experienced in FDA and EMA regulations for investigational and new drug application (在美制药界工作二十多年，目前在一著名生化公司做临床和新药申报工作，熟悉FDA和EMA新药审批过程）

微信：bayueguizi

FDA 关于新冠疫苗紧急授权考量的解释：Emergency Use Authorization for Vaccines Explained：https://www.fda.gov/vaccines-blood-biologics/vaccines/emergency-use-authorization-vaccines-explained

FDA guidance : Emergency Use Authorization for Vaccines to Prevent COVID-19: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/emergency-use-authorization-vaccines-prevent-covid-19

FDA 在NEJM上发表的文章：Emergency Use Authorization of Covid Vaccines — Safety and Efficacy Follow-up Considerations。 https://www.nejm.org/doi/full/10.1056/NEJMp2031373?cookieSet=1

Pfizer 和Moderna 宣布2021年会申请BLA (full approval for COVID vaccine ).

FDA In Brief: FDA Advises Against Use of SARS-CoV-2 Antibody Test Results to Evaluate Immunity or Protection From COVID-19, Including After Vaccination:: https://www.fda.gov/news-events/press-announcements/fda-brief-fda-advises-against-use-sars-cov-2-antibody-test-results-evaluate-immunity-or-protection

推荐几个科普Youtube视频：

UC Riverside professor Roger Seheult的Med Cram，现在不定期更新。

UCSF住院药剂师Dr Cavin Jiang 的YouTube 医痴的木头屋，疫情以来他一直在科普和做公益讲座。

U of Minnesota 的 Dr Osterholm 每周一次的Podcast