Which of the following is true: a. FDA assures that pregnant women are enrolled

Question

Which of the following is true:

a. FDA assures that pregnant women are enrolled in investigational drug trials before a product is

used when there is substantial use in women

b. FDA has the authority to stop the distribution of an approved drug until studies are done in

pregnant women

c. An entire IND drug development program can be put on hold, when the product is intended for

a serious condition where there is unmet need, and the trials exclude women of childbearing

potential

d. Animal studies of drug induced birth defects so imperfectly predict human birth defects that

FDA does not require them

Explanation / Answer

Correct answer may be C

. An entire IND drug development program can be put on hold, when the product is intended for a serious condition where there is unmet need, and the trials exclude women of childbearing potential.

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