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A physician reports to a manufacturer that a patient was hospitalized with acute sepsis after treatment with an approved device. This side effect is not listed in the package insert. This event must be reported by the manufacturer to FDA no later than: A. 5 calendar days. B. 15 calendar days. C. 30 calendar days. D. The next quarterly or annual report. - ✔✔Explanation: B. There are no 15 day reports included in MDR regulations. 15 Day reports are required b by drug reporting regulations. The correct answer is: C
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Under the IDE regulation, all of the following must be reported to the sponsor within five working days EXCEPT: A. A deviation from the investigational plan. B. Withdrawal of IRB approval. C. An unanticipated adverse device effect. D. Use of a device without informed consent. - ✔✔Explanation: B. Withdrawal of IRB approval is reported within five days. The correct answer is C. When design verification testing is being performed by a manufacturer, which element is NOT included as a potential requirement under device design verification section of the QSR? A. Identification of the design B. Software validation
The correct answer is A. A manufacturer of the following must file an IDE before conducting a human clinical study? A. A device in commercial distribution before 28 May 1976 when used or investigated in accordance with its indications in labeling in effect at that time. B. A device intended solely for veterinary use. C. A custom device being studied for safety and effectiveness. D. A device in commercial distribution before 28 May 1976 when used or investigated in accordance with its indications in labeling in effect at that time. And a device intended solely for veterinary use. - ✔✔Explanation: C. While a custom device may be studied in humans without an IDE, if its safety and efficacy are being studied in support of commercial marketing, an IDE must be file (21 CFR 812.2(c)(7)) The regulatory affairs professional performs all of the following prior to submitting a PMA to FDA
EXCEPT:
A Preparing criteria for the MDR report. B. Preparing a brief statement of reasons for noncompliance with regulation. C. Identifying all omissions in PMA content. D. Reviewing, organizing and checking adequacy of data pertaining to safety and efficacy evaluation. - ✔✔Explanation: B. This item is required by 814.20(b) The correct answer is A Which of the following sections is required in a PMA? A. Patent certification information. B. A copy of quality manual. C. An economic cost/benefit assessment. D. A discussion of benefit and risk considerations. - ✔✔Explanation:
A. Certificate of Free Sale. B. Customs Tax Stamps. C. No clearance required. D. FDA receipt for sample Form-484. - ✔✔Explanation: C. There are no FDA export requirements for approved products. C. No clearance required. Fully quality-assured individual toxicology reports are not required for submission of an initial IND application. However, finalized and fully quality assured reports should be available to FDA upon request within what period of the start of the human study? A 90 days. B. 120 days. C. One year.
D. The final report is only required in the submission for the NDA - ✔✔Explanation: A See FDA "Guidance for Industry Q & A: Content and Format of INDs for Phase 1 Studies of Drugs, Including Well-Characterized, Therapeutic, Biotechnology-Derived Products." OctoBer 2000. The correct answer is B. With respect to drug product distribution procedures, a distributor is required to do all of the following EXCEPT: A. Establish a system whereby the oldest approved stock of a drug is distributed last. B. Establish written procedures describing the distribution of drug products. C. Establish a system whereby the oldest approved stock of a drug is distributed first.
D. Include its name and address in the upper left hand corner of the envelope. - ✔✔Explanation: Reference 21CFR §200.5. The correct answer is C. A regulatory affairs professional wants to schedule a pre-NDA meeting with the FDA. He or she should: A. Write a letter to the FDA. B. Request a Type B meeting as an amendment to the IND. C. Call the project manager and set up a date over the phone D. Email the division director with a list of three dates, 30 days into the future. - ✔✔Explanation: B. See the CDER/CBER guidance published in February 2000 entitled "Formal Meetings With Sponsors and Applicants for PDUFA Products".
The correct answer is B. Which one of the following statements is NOT true with respect to both Investigational New Drug Applications (INDs) and Investigational Device Exemptions (IDEs) for significant-risk products? A. The investigational product must be manufactured in full compliance with cGMP. B. Clinical studies must be approved by an Institutional Review Board. C. The IND or IDE goes into effect 30 days after FDA receives the application, unless FDA notifies the sponsor otherwise. D. The application must include an environmental impact statement that contains a claim for categorical excIusion or an environmental assessment. - ✔✔Explanation: A. Devices under approved IDEs are exempt from cGMP regulations except for design control requirements; investigational new drugs must be compliant with cGMP for finished pharmaceuticals (21CFR 211).
A regulatory affairs professional is developing SOPs for a firm to cover compliance with drug GMPs. The firm's SOPs should require out-of-specification (OOS) test results to be completed within: A. A timely manner. B. 20 days. C. 30 days. D. 45 days. - ✔✔Explanation: A. 21 CFR 211.192 require an investigation, but do not specify a time frame. October 2006 GMP guidance states that investigation of out-of-specification test results should be timely. The correct answer is A. Which information MUST be included in an IND?
A. A list of all components used in the manufacture of the investigational drug product. B. A statement of compliance with applicable GMPs. C. Statistical methods to be used in the analysis of phase II and III clinical trials. D. Results of accelerated stability studies on three lots of the investigational drug product. - ✔✔Explanation: See 21 CFR 312.23(a)(6)(iii). The correct answer is A Which of the following documentation is NOT included in a Biologics License Application? A. Stability data. B. Product labeling. C. GLP compliance statement(s). D. Overall quality summary. - ✔✔Explanation:
To be legally effective, a witness must observe the informed consent process at which of the following times? A. When the study subject is a minor. B. When the elements of informed consent are presented orally C. When the consent is obtained from the subject's legal representative. D. When the elements of informed consent are written in a foreign language. - ✔✔Explanation: B. FDA regulations require a witness to an oral presentation of elements of informed consent to the subject or the subject's legally authorized representation. 21 CFR 50.27(b)(2). The correct answer is B. FDA will do a for-cause inspection of an investigator if the investigator:
A. Conducts a number of pivotal NDA studies. B. Is only participating in a small number of studies. C. Appears to have an excessive number of study projects. D. Consistently reports results different from other investigators. - ✔✔The correct answer is D. Which of the following federal laws includes information about ANDA submissions? A. Antibiotic Amendments of 1945. B. Durham-Humphrey Amendment of 1951. C. Drug Amendments of 1962. D. Drug Price Competition and Patent Term Restoration Act of 1984. - ✔✔Explanation: D. This Act permitted manufacturers to use abbreviated NDAs to gain approval for generic versions of approved drugs whose patents had expired.
C. The change does not have to be reported because it is an OTC drug. D. Not enough information. - ✔✔Explanation: B. It is unclear from this question if the OTC drug product is an OTC monograph product for which there would be no FDA administrative file to report the change to, or if this is an NDA-OTC drug product (versus an NDA-Rx drug product). For an NDA-OTC drug product, the company would have an approved NDA file where they could send a supplement for review. The correct answer is D. All of the following are additional IND submissions to FDA EXCEPT: A. Information amendments. B. Protocol deviations. C. IND safety reports. D. Annual reports. - ✔✔Explanation:
B. Protocol deviations are departures from the specific procedure as described in the protocol or protocol amendment without prior IRB approval. They need to be reported to the sponsor and are reported to the IRB, per their individual guidelines. The correct answer is B. A minimum of 10 tablets is required to perform all tests for product release. To meet GMP requirements, reserve samples must be at least: A. 10 tablets. B. 20 tablets. C. 30 tablets. D. 100 tablets. - ✔✔Explanation: The reserve sample consists of at least twice the quantity necessary for each required test. 21 CFR 211.170(a).
