CITI Training Test Prep | 134 Questions with 100% Correct Answers

What must you file before conducting human clinical trials with an experimental drug? - IND application (Form FDA 1571) During the clinical development phase of the IND process, what must sponsors do? - Maintain current IND application by amending IND with new Form FDA 1571 and providing FDA with: safety updates copies of new protocols FDA 1572 Annual Progress reports this document notifies FDA of relevant changes in investigators conducting clinical trials under the IND. - Form FDA 1572 What is the timeline of drug development? - Preclinical trials, IND Submission, Clinical Development (Phase I-III), NDA submission, Marketing (Phase IV) When does a sponsor submit the IND? - Prior to clinical development phases (human trials). *30 day process. What is the NDA? - New Drug Application, submitted prior to Phase IV marketing phase. How long does the NDA submission take? -