US RAC Review Questions And Answers 2024 RAPS Modules Updated with Complete Solution.

US RAC Review Questions And Answers 2024 RAPS Modules Updated 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 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 C) to FDA within 14 calendar days D) to FDA and investigators within 7 working days 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 D) Phase III pivotal study US RAC Review Questions And Answers 2024 RAPS Modules Updated with Complete Solution. 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 A) Request Special Protocol Assessment As a regulatory affairs professional, you are responsible for developing the content of an information 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 summary D) Provide appropriate clinical summary 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 B) 505 (b) (2) 8) If FDA 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 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 B) Change in the technical grade of an excipient, same specifications and use C) Add a warning statement to prescribing information D) Process change outside the validated range D) Process change outside the validated range 10) Which of the following products would not be regulated by CDER? A) Therapeutic proteins B) Vaccines C) Chemically synthesized small molecules D) Monoclonal antibodies B) Vaccines 11) Which of the following devices would be regulated by CBER? A) Warming device B) Blood pressure cuff C) HIV diagnostic test kit D) Capillary blood collection tube C) HIV diagnostic test kit 12) You are developing a combination product and believe the primary mode of action will designate the product as a drug as opposed to a device. Your first course of action is to: A) Develop written rationale describing the product, mode(s) of action, and proposed classification as a drug B) Submit a formal request for designation to the Office of Combination Products C) Call the CDER review division D) Check the FDA website for information, eg, other combination/similar products D) Check the FDA website for information, eg, other combination/similar products 13) For a medical Device, what is NOT a responsibility of the US Agent for a Foreign Establishment? A) Report adverse events under the Medical Device Reporting regulation B) Assisting FDA in communications with the foreign establishment, C) Responding to questions concerning the foreign establishment's products that are imported or offered for import into the United States, and D) Assisting FDA in scheduling inspections of the foreign establishment. A) Report adverse events under the Medical Device Reporting regulation 14) Which Congressional Act provided Statutory Authority to FDA to regulate medical devices? A) Safe Medical Devices Act of 1990 (SMDA) B) Medical Device User Fee and Modernization Act of 2002 (MDUFMA) C) Federal Food, Drug, Cosmetic Act (FDC Act) D) Medical Device Amendments of 1976 (MDA) D) Medical Device Amendments of 1976 (MDA) 15) Which of the following is NOT a key Medical Device submission which directly leads to marketing permission from FDA? A) 510(k), Pre-market Notification, Part 807 B) HDE, Humanitarian Device Exemption, Part 814 C) Premarket Approval (PMA), Part 814 D) IDE, Investigational Device Exemptions, Part 812 D) IDE, Investigational Device Exemptions, Part 812.