US RAC Review Questions and Answers RAPS Modules 2024 with complete solution
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RAC Devices
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RAC Devices
US RAC Review Questions and Answers RAPS
Modules 2024 with complete solution
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 ...
US RAC Review Questio ns and Answers RAPS Modules 2024 with complete solution 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 coll ect 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 - Answer ✔️✔️-C) You intend to collect blood samples from subjects to look f or 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 escalatio n PK study in healthy volunteers C) Multiple dose PK study in healthy volunteers D) Single dose escalation study in hypertensive patients - Answer ✔️✔️-B) Single dose escalation PK study in healthy volunteers A sponsor must report an unexpected, fatal or l ife-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 C) to FDA within 14 calendar days D) to FDA and investigator s within 7 working days - Answer ✔️✔️-B) to FDA and investigators within 7 calendar days Which of the following is a covered study as defined under Financial Disclosure regulations: A) Phase I dose escalation study B) Phase I/II Pharmacokinetic Study C) A large open label safety study conducted at a large number of study sites D) Phase III pivotal study - Answer ✔️✔️-D) Phase III pivotal study Your company is developing a product to treat a serious and life threatening disease. A clinically meaningful, well established primary endpoint will be used in the pivotal studies. Which regulatory strategy might you select prior to commencing Phase 3 studies? A) Request Special Protocol Assessment B) Request Fast Track Designation C) Request Priority Review D) Approval under Subpart H, Accelerated Approval of New Drugs for Serious or Life Threatening Illnesses - Answer ✔️✔️-A) Request Special Protocol Assessment As a regulatory affairs professional, you are responsible for developing the content of an informatio n package for a Type B meeting with FDA. Your primary objective is to: A) Reach consensus on content from contributing team members B) Ensure content is sufficient to support meeting objective(s) and questions to FDA C) Provide appropriate preclinical sum mary D) Provide appropriate clinical summary - Answer ✔️✔️-B) Ensure content is sufficient to support meeting objective(s) and questions to FDA You, a regulatory affairs professional, are assessing the information to be submitted in support of a marketing application for a new dosage form for a listed drug. You lack right of reference to one key preclinical report. Which type of application will you prepare for submission? A) 505 (b) (1) B) 505 (b) (2) C) 505 (j) D) PMA - Answer ✔️✔️-B) 505 (b) (2) 8) If F DA were to invoke the Application Integrity Policy, which of the following is a possible outcome? A) Defer review of pending application(s) B) "File" a marketing application at the 60 day review C) Grant a waiver or deferral for pediatric clinical study D) Approve a marketing application - Answer ✔️✔️-A) Defer review of pending application(s) 9) Which of the following supplements to an approved NDA/BLA must be approved by FDA prior to distributing product made using the change? A) Make change(s) to comply with USP
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