RAC Practice Exam 1 Latest Update 2024 Questions and Verified Correct Answers Guaranteed Success A 505(b)(2) NDA is not an appropriate regulatory submission for the approval to market
a - CORRECT ANSWER: New chemical entity when the sponsor has a right of
reference to all applicable published studies
A clinical investigator will conduct Phase I pharmacokinetic studies on your drug product. This same investigator also receives a $30,000 retainer to be on the speaker's bureau for another of your company's products. What information related to this investigator must be included with your IND
submission? - CORRECT ANSWER: No additional forms are required.
Phase I pharmacokinetic studies are not covered studies, and therefore do not need financial certification or disclosure
A company begins to market its new device, a pacemaker (Class III) the same day that its regulatory professional mails the Premarket Approval Application (PMA) to FDA. The pacemaker is considered: - CORRECT ANSWER: Adulterated
A company has submitted its NDA for review. An NDA amendment can be submitted to change or add information to a not yet- approved NDA. When must new safety information be submitted in a safety update
report? - CORRECT ANSWER: Four months after the initial NDA submission (120 day
safety update)
A company is developing an (unapproved) drug-device combination product but is not sure to which center it should submit its marketing application. The company should first
submit - CORRECT ANSWER: A Request for Designation to the Office of Combination
Products
A company is planning to develop a sunscreen with an ingredient consistent with its published monograph for marketing within the US. What type of filing does the company
have to submit - CORRECT ANSWER: OTC Application
A company is using a clinical research organization (CRO) to develop the protocol and monitor the clinical investigators for its clinical trial. The regulatory professional may interact with the CRO in which of the following situations?A Making presentations to the reviewing IRBs.B Making presentations to the reviewing division C Witnessing the signing of patient consent forms D Arranging for FDA investigators to observe treatment of subjects at clinical sites -
CORRECT ANSWER: Making presentations to the reviewing division at FDA.
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A company's supplier of the active drug substance for the company's OTC monograph drug product informs the company that the supplier will be moving its production of the drug substance from the current plant to a new manufacturing plant in another state in six months. The supplier states that all manufacturing processes will remain the same and the specifications will not change.The company intends to qualify the change suitably. How should the company report
the change to FDA? - CORRECT ANSWER: The change does not have to be reported
because it is an OTC monograph drug
A deficiency letter may be issued to a company during review of a Biologics License Application (BLA) for which of the following?A Clinical testing was not performed at enough sites B The BLA was not submitted electronically
- C The sponsor failed to have a meeting with FDA
D The submission did not include a Drug Master File - CORRECT ANSWER: Clinical
testing was not performed at enough testing sites.FDA will not approve a BLA if it does not contain adequate clinical data (which may be affected by the number of sites where testing was performed) to demonstrate safety and efficacy.
A drug manufacturer is assembling a clinical evaluation plan for a new chemical entity (NCE) to include in an IND submission. Which of the following NCE studies DOES NOT need to be included by the manufacturer in the clinical trial registry at www.clinicaltrials.gov?A Phase I studies, B Phase II studies, C Phase III studies,
D None of the above - CORRECT ANSWER: A
A firm is preparing a 510(k), premarket notification to FDA for an in vitro diagnostic test, a microhematocrit analyzer that, among other intended uses, can determine the hematocrit of a blood donor prior to donation of a blood product. The firm should address the 510(k) submission to: - CORRECT ANSWER: CBER
A firm received a raw material for one of its drug products. The raw material was placed into quarantine and sampled appropriately. Sample containers should be identified so
that the following information can be determined - CORRECT ANSWER: The material
name, lot number, the container from which the sample was taken, name of person who collected the sample, and the date on which the sample was taken.
A firm submitted and received approval for a clinical trial for IRB approval for a study involving children in which there would be no prospect of direct benefit to the individual subjects. On what basis could this study be approved by the IRB? - CORRECT
ANSWER: The trial was likely to yield generalized knowledge about the subject's
disorder or condition and all other regulatory requirements were met.
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