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Study Guide #2.pdf - RGA 6000 - Introduction to FDA...

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RGA 6000 - Introduction to FDA Pharmaceutical RegulationNortheastern UniversitySpring 2022 -Term BWeek 3Page 1 of 2Study Guide 2Chapter 2:What Is an IND?1.Which legislation requires that all new drugs have an approved marketing applicationbefore they can be shipped in interstate commerce?2.What is an IND?What is the purpose of an IND?When is an IND required?3.What is a clinical hold?4.What is the primary concern of the FDA when reviewing an IND application?5.An IND is not required under which two conditions?6.What is the IRB?7.What type of meeting is a pre-IND meeting?8.What is the CFR that outlined information regarding the IND?9.What is Common Technical Document (CTD)?10. What is the importance of FDA Form 1571?11. Each submission of the IND must be consecutively numbered, starting with the initialIND application, which is numbered _____________________.12. What are the three important commitments the sponsor is making to the FDA whensigning Form FDA 1571?13. What is an IND amendment?14. What is an IND safety report?15. What is an IND annual report?16. In general, what type of information is included in the Chemistry, Manufacturing andControls section of the IND?17. What type of information is included in the pharmacology and toxicology section of theIND?18.
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Pharmacology, Pharmaceutical drug, Good Laboratory Practice

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