An investigational product may include a drug, vaccine, biological product, or placebo. An investigational product may include a drug, vaccine, biological product, or placebo.
IND labeling must include a caution statement limiting it to investigational use. IND labeling must include a caution statement limiting it to investigational use.
An IND may be given only under supervision by the PI or sub-investigator. An IND may be given only under supervision by the PI or sub-investigator.
Which phase is generally the first study of an IND in humans? Which phase is generally the first study of an IND in humans?
Phase 3 trials usually include several hundred to several thousand participants. Phase 3 trials usually include several hundred to several thousand participants.
A sponsor conducting a clinical trial involving an IND must submit what to FDA? A sponsor conducting a clinical trial involving an IND must submit what to FDA?
An IND generally goes into effect 30 calendar days after FDA receives it unless hold or earlier permission. An IND generally goes into effect 30 calendar days after FDA receives it unless hold or earlier permission.
Sponsors must notify FDA of unexpected fatal or life-threatening experiences no later than: Sponsors must notify FDA of unexpected fatal or life-threatening experiences no later than:
