Hi,
we are developing DNA therapeutic cancer vaccines. According to FDA guidance of plasmid vaccines for infectious disease infection, biodistribution studies may be waived for DNA vaccines produced by inserting a novel gene into a plasmid vector previously documented to have acceptable biodistribution/integration profile.
Shall we say that these guidelines also apply to cancer therapeutic cancer vaccines? our cancer therapeutic vaccines were using same plasmids. so we'd like to waived distribution studies using previous data that used different antigen with same plasmids.
thank in advance for your advise. ------------------------------
byungmin kim
Director of company operation
Gangnam-gu
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