Not sure what to make of this video - its about the clinical trial guidance the FDA are allowing/advising regarding cell and gene therapy trials occurring in the COVID 19 environment. I had a brief look at it but most of it is over my head! Some takeaways I picked up were about the restrictions and difficulties the COVID 19 means for companies applying for trials. Im assuming that its all okay for MSB given ours are in the bag so to speak! Thought some of you might be interested and could perhaps interpret if there is anything significant for MSB/competitors.
This is the blurb from the video: View the webinar playback featuring ARM and FDA representatives Tejashri Purohit-Sheth and Ilan Irony from the Office of Tissues and Advanced Therapies, Center for Biologics Evaluation and Research, as they discuss the effect of COVID-19 (coronavirus) on cell and gene therapy clinical trials. Discussion topics include assuring the safety of trial participants, maintaining compliance with good clinical practice (GCP), and minimizing risks to trial integrity during the COVID-19 pandemic.
Not sure what to make of this video - its about the clinical...
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