https://www.youtube.com/watch?v=43XAc5iDN9k
If anyone is interested, this is a recent 40 minute conversation between Dr Howard Bauchner from JAMA and Dr Peter Marks, the director of Centre for Biologicals Evaluation and Research (CBER) at FDA, talking about process for Vaccine evaluation, but essentially going through in detail differences, communication and processes for biologics EUA and BLA’s.
in detail
very interesting
MSB to dispute FDA finding in Type A meeting, page-519
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