I need your help in understanding the rules btw switzerland vs Germany vs US in the following;
if we have a lysate vaccine that can be given to one patient outside a context of a clinical trial what are the licenses necessary for this? like for example they do a lot of stem cell injections in private hospitals in the US, can it be possible without a clinical trial setting?
Any advises? Thanks,
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Vijaya Dandamudi
Assoc. Director of Regulatory Affairs
University of Pennsylvania
Chester Springs PA
United States
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