Question

With respect to Investigational New Drugs (INDs):

a. When a new protocol is submitted to an existing IND the sponsor must wait 30 days before proceeding

b. An IND can be put on hold when it does not include pregnatn women in the IND program

c. A phase 1 study can be put on hold, although safe, if "the plan or protocol for the investigation is clearly deficient in design to meet its stated objectives."

d. An IND is not required for pharmacokinetic studies for the purpose of generic drug approval

e. All of the above

Answer 1

When a new protocol is submitted to an existing IND the sponsor must wait 30 days before proceeding

The IND is for the study of an investigational drug intended to treat a life-threatening disease or condition that affects both genders, and men or women with reproductive potential who have the disease or condition being studied are excluded from eligibility because of a risk or potential risk from use of the investigational drug of reproductive toxicity. Women with reproductive potential do not include pregnant women. Life-threatening illnesses or diseases are defined as "diseases or conditions where the likelihood of death is high unless the course of the disease is interrupted