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Gene therapy vectors with minor modifications may not require new IND -- FDA addendum to PTC.

Executive Summary

GENE THERAPY VECTORS WITH MINOR MODIFICATIONS MAY NOT REQUIRE NEW IND, an FDA draft "Addendum to The Points to Consider in Human Somatic Cell and Gene Therapy" states. The draft addendum to the 1991 points to consider document, which provides more details than the earlier points to consider, especially with regard to in vivo gene therapies, will be discussed at a Feb. 28-29 meeting of FDA's Biologic Response Modifiers Advisory Committee ("The Pink Sheet" Feb. 5, In Brief). Comments are due March 28.



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