US RAC Review Questions RAPS Modules

In which situation is an IND not required? A) You intend to conduct a clinical trial with an investigational new drug B) You intend to conduct a clinical trial with an approved drug to support a marketing application for a new indication C) You intend to collect blood samples from subjects to look for biomarkers or pharmacogenetic information D) You intend to conduct a clinical trial using 2 of your approved drugs in a new combination - C) You intend to collect blood samples from subjects to look for biomarkers or pharmacogenetic information In the clinical development plan for an investigational antihypertensive drug, which of the following studies would typically be conducted first: A) 1 month repeat dose toxicology study B) Single dose escalation PK study in healthy volunteers C) Multiple dose PK study in healthy volunteers D) Single dose escalation study in hypertensive patients - B) Single dose escalation PK study in healthy volunteers A sponsor must report an unexpected, fatal or life-threatening experience believed to be associated with an unapproved drug/biologic: A) to FDA, investigators and IRBs within 7 calendar days B) to FDA and investigators within 7 calendar days