RAC Practice Exam 1 - Questions and Answers (Complete Solutions) Which of the following is NOT required for compliance under 21 CFR Part 11 (electronic
... [Show More] records and electronic signatures)? A Manually generated timestamped audit trails to record the date and time of operator entries and actions that create, modify or delete electronic records. B Validation of systems to ensure accuracy C Authority checks to ensure that only authorized personnel can create, modify or delete electronic records. D Establishment of and adherence to written procedures The final authority for ensuring the adequacy of an Investigational New Drug (IND) informed consent document resides with the: Institutional Review Board (IRB) A sponsor wishes to obtain permission from FDA to submit an ANDA for a drug product that varies from the Reference Listed Drug (RLD) in route of administration, dosage form, or strength, but anticipates that the labeling will be identical to that of the RLD. What process should be used to apply for that permission from FDA? Suitability Petition A 505(b)(2) NDA is not an appropriate regulatory submission for the approval to market a New chemical entity when the sponsor has a right of reference to all applicable published studies Distribution records for drug products must reference or contain: Name and address of the consignee A mid-sized pharmaceutical company negotiated with FDA to submit a draft Package Insert (PI) and patient medication guide (MedGuide) in annotated Word format for initial FDA review, and committed to submit the Labeling in Structured Product Label (SPL) format upon approval of their product. What is the preferred timeline for this pharmaceutical company to submit the SPL formatted labeling upon product approval? 14 days Adverse event reporting for a marketed biologics product is NOT required for: Diagnostic non-invasive test kits The quality assurance manager of a small company consisting of 12 employees is the only internal auditor for the company and has been performing all internal quality system audits for three years. This does not meet the requirements for performing internal quality systems audits because Auditor independence has not been ensured. You have modified your 510(k)-cleared device with a Special 510(k). In which case would a Special 510(k) not be appropriate for the device? You have changed the primary mechanism of action. Which Premarket Approval Application (PMA) supplements are NOT subject to user fee exemption? Real Time Supplement A medical device company allows its sales force to maintain a product inventory in the field. The device has an expiration date indicated on its labeling. A sales person notes that one of his products has expired and contacts the headquarters office for direction. He is told to return the product to the headquarter office for replacement. The return of this product is considered as what type of recall? Not a recall—it is considered normal stock rotation 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 A Request for Designation to the Office of Combination Products A medical device company is developing a product with drug, biologic and device components. The product and indication have not been previously classified by FDA. What is the most appropriate regulatory pathway? A Request for Designation (RFD) should be sent to the Office of Combination Products (OCP) at FDA to determine the primary mode of action (PMOA) and assign the agency with primary jurisdiction. FDA's Office of Generic Drugs (OGD) remains committed to the "first-in, first-reviewed" review order for the reviewing original Abbreviated New Drug Applications (ANDAs), amendments and supplements unless there is a specific reason to expedite an application. What is NOT a specific reason to grant expedited review? Products that show evidence of safety and effectiveness in a new subpopulation 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: CBER Notice of Intent to Revoke license can be issued for the following reason, EXCEPT A Unable to gain access to the manufacturing plant B Licensed product are no longer safe and effective
C Failure to report serious adverse event D Manufacturer fails to conform to applicable standards What is the formal early collaboration meeting that was implemented through the Food and Drug Modernization Act (FDAMA)? Agreement Meeting The Agreement Meeting is a formal meeting to agree upon the parameters of the investigational plan. When a meeting request is received by FDA, the meeting will be held within 30 days. The agreements made at the meeting are provided in writing to the sponsor and are binding on FDA. Regulatory Reference: Early Collaboration Meetings Under the FDA Modernization Act; Final Guidance for Industry and for CDRH Staff (February 2001). A US medical device contract manufacturer has customers for whom it manufactures medical device components (parts) and finished medical devices. To date, all products have been either parts for Class II medical devices or Class II finished medical devices. The manager of new business contacts the regulatory manager to assess the impact of a possible new customer involving a Class III device. What is the first question the regulatory manager should ask in order to begin assessing the impact of Class III on plant operations? Is it a component or device that would be manufactured? The following biological products are regulated by CBER EXCEPT: A Immunizing toxoids B Monoclonal antibodies for in vitro use C Monoclonal antibodies for in vivo use D Infusion of animal sourced cells into a hum You work for a company that is developing an autologous cellular therapy product. FDA has informed your company that your product will be regulated as a HCT/P (Human Cells, Tissues and Cellular and Tissue-Based Product). Based on this information, which of the following regulatory requirements will your company need to be compliant with when manufacturing the product? All Subparts of 21 CFR 1271 except Subpart C (Donor Eligibility) 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? Four months after the initial NDA submission (120 day safety update) A television advertisement that you have been asked to review prior to release discusses the benefits of the drug in detail for 25 seconds, and then names all the major side effects associated with the product in the last five seconds. You should advise that: The benefits and side effects of the drug should be presented with the same level of scope, depth and detail. At the completion of a Preapproval Inspection where a deficiency was noted, a meeting is convened to discuss what document? Form FDA 483 Due to market interest, a new strength for an existing combination OTC product for use in the adult population (labeled as 12 years of age and older) has been developed, and appropriate data have been gathered to support safety and efficacy. The existing product is regulated by a final monograph, but does not contain labeling for use of the new strength in adult populations. What options could the company utilize to modify the monograph in order to gain FDA approval to market the new dosing regimen? New Drug Application; Citizen's Petition; and Time and Extent Application If a company is planning to market a medical device that is substantially equivalent to a device marketed before 1976, it can use which regulatory path? 510(k) If a device failure is occurring with greater than expected frequency and investigation of the problem indicates improper use by the end user, which of the following should occurs? A The labeling is revised B The product is recalled C The product is redesigned D A Dear Doctor letter is issued An Investigational New Drug Application (IND) goes to "Inactive Status" when: No subjects are entered into clinical trials for a period of two years or IND is on clinical hold for one year. Financial disclosure is required for investigators who, during the time the clinical investigator is carrying out the study and for one year following the completion of the study, have: Been a prior employee of the sponsor company and own stock worth more than $50,000 (US) An Investigational New Drug Application (IND) was submitted to FDA. New animal toxicology data is obtained and will be submitted to FDA as: As an information amendment submitted no more than every 30 days. Your company is planning to market an allergen patch test. Which center should oversee the approval process? CBER
FDA is authorized to regulate advertising for what type(s) of medical devices? Restricted devices Your company wishes to seek approval of a combination of individually approved anti-hypertensive and anti-diabetic drugs. However, there is no Reference Listed Drug for the proposed combination. Which regulatory pathways is most applicable? 505(b)(2) Which of the following statements is TRUE for Phase 2 clinical investigations of a previously untested drug? A They are designed to determine the metabolic and pharmacokinect effects B They are intended to gather additional info C They are conducted to determine the common short-term side effects and risks associated with the drug D They are performed to provide an adequate bioavailability of the drug FDA has granted approval to market a product and has required a postmarketing commitment from the sponsor. The sponsor is required to gather additional information about the product's safety and use. Under what situations could FDA require the postmarketing study? Approval granted in accordance with accelerated approval provisions, or the study is a deferred pediatric study under PREA. All of the following choices are examples of type B meetings with FDA, except: A PreIND meetings B Critical path meetings C End of Phase 2 meetings D PreNDA meeting For a medical device's product storage and handling system, each manufacturer shall establish and maintain all of the following EXCEPT: A Separate rooms or cages for release and quarantined material B Procedures for the control of storage areas and stock used for shipping supplies C Environmentally controlled areas for product D Procedures for rotation of stock. There is no storage and handling requirement for shipping supplies. 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 [Show Less]