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Re: slcimmuno post# 139634

Wednesday, 02/10/2016 8:07:02 PM

Wednesday, February 10, 2016 8:07:02 PM

Post# of 402178
Now I'm convinced:

267 Sec. 506
FEDERAL FOOD, DRUG, AND COSMETIC ACT
(1) IN GENERAL
.—The Secretary shall, at the request of the
sponsor of a new drug, facilitate the development and expedite
the review of such drug if it is intended, whether alone or in
combination with one or more other drugs, for the treatment
of a serious or life-threatening disease or condition, and it dem-
onstrates the potential to address unmet medical needs for
such a disease or condition, or if the Secretary designates the
drug as a qualified infectious disease product under section
505E(d). (In this section, such a drug is referred to as a ‘‘fast
track product’’.)

http://legcounsel.house.gov/Comps/Federal%20Food,%20Drug,%20And%20Cosmetic%20Act.pdf



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