FDA required Reproductive Toxicology Studies

Minter, Robb minterr at DYNPORT.COM
Thu Jan 28 13:52:01 EST 1999

I am looking for information on the newly required studies required by the
FDA that includes Reproductive Toxicology for new vaccines being developed
for licensure in the United States.  There is very little literature on
these studies as they are new.  Animal reproductive studies on vaccines have
not been required in the past because the vaccines are not repeatedly
administered on a daily basis.  But rather drawn out to include only a few
inoculations over weeks or months.  I would argue that the studies would
examine the effects of estrous cycles, ELISA to determine antibody response,
and histopathology of the testes (spermatogenesis) Furthermore, these new
requirements may be a result of the DoD's interest in such studies.  Note
that the studies should have no affect on the licensure status other than to
amend the package insert stating the results of the studies.  More
specifically, once we identify what studies need to be done, I need to
develop a cost/schedule model.  I feel confident that these studies would be
conducted using an animal model (murine to begin).  Any one have ideas
who/where to find such information?  I have already spoken with SAIC - but
no luck.  Any help is appreciated.

Robb Minter

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