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All RAC Practice Exam – Questions/Solutions
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All RAC Practice Exam – Questions/Solutions
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All RAC Practice Exam – Questions/SolutionsAccording to the Quality System Regulation, when an investigation of a complaint is conducted all of the following are requirements for inclusion in the record of the investigation EXCEPT:
A. The dates and results of the investigation
B. The nature and details of the complaint
C. Changes in procedures correcting quality problems
D. Any reply to the complainant ✔ Ans - C. Changes in procedures correcting quality problems
The requirement is for corrective and preventative action and only needed if a
corrective action was taken as a result of the investigation. See Sec. 820.198. Complaint Files.
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
V. 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 ✔ Ans - A. A list of all components used in the manufacture of the investigational drug product
Compassionate Use ✔ Ans - some of the ways of making unapproved products available to patients, there is no FDA regulation or policy defining a "compassionate use." "single patient IND" study, OR wider use would usually take place under a "treatment IND" or "treatment protocol" under an existing commercial IND.
Which of the following is NOT true of an Advisory Committee?
A. Advisory Committee meetings can include an oral presentation from a patient advocacy group.
B. Advisory Committee members are selected without regard to race, ethnicity, sex, age or religion. C. Advisory Committees provide advice to FDA on safety and effectiveness of drugs.
D. Advisory Committees recommend whether a drug should be approved and do not provide advice on product labeling or clinical trial design. ✔ Ans - D. Advisory Committees recommend whether a drug should be approved and do not provide advice on product labeling or clinical trial design. (The Advisory Committee can review and make recommendations on any matter
before the FDA; see 21 CFR 14.1(a)(1). The Advisory Committee advises for human
prescription drugs "on the safety and effectiveness, including the labeling and
advertising." See 21 CFR 14.160(a).)
A US company will now manufacture a product that was developed by its British subsidiary to market for the first time in the US. The product is marketed in the EU. A project team gathered by the regulatory professional to review the information available for regulatory submission to FDA should:
A. Focus on labeling and marketing since mutual recognition does not require complete technical review
B. Include R&D production, marketing, QA and clinical research for a thorough
review
C. Summarize financial data and distribution data which are normally required to be submitted to FDA
D. Not be necessary if a Common Technical Document has been prepared by the subsidiary ✔ Ans - B. Include R&D production, marketing, QA and clinical research for a thorough review
A regulatory affairs professional wants to schedule a pre-NDA meeting with FDA. He or she should:
A. Write a letter to FDA requesting a Type A meeting as an amendment to the IND
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 for a Type C meeting
D. Email the division director with a list of three dates, 30 days into the future ✔ Ans - B. Request a Type B meeting as an amendment to the IND See the CDER/CBER guidance published in February 2000 entitled Formal Meetings With Sponsors and Applicants for PDUFA Products.
Following the "elixir of Sulfanilamide" tragedy, public outcry led to the 1938 passage of A. The Pure Food and Drug Act
B. The Federal Food Drug and Cosmetic Act
C. The Kefauver-Harris Drug Amendments
D. The Public Health Service Act ✔ Ans - B. The Federal Food Drug and Cosmetic Act
What products are exempt from the Prescription Drug User Fees Act (PDUFA)? A. Generic drugs only
B. Orphan drugs and cosmetics only
C. OTC drugs, cosmetics, generic drugs and medical devices
D. Prescription drugs marketed before 1992 ✔ Ans - C. OTC drugs, cosmetics, generic drugs and medical devices
MDUFMA is an acronym for:
A. Managing Department for the Unification of Foreign Medicinal Applications
B. Medical Device Users Fee and Modernization Act
C. Modernization of Devices Used for Medical Anomalies
D. Medical Device Universal Fees for Marketing Applications ✔ Ans - B. Medical Device Users Fee and Modernization Act
Which is not a division of the FDA?
A. CDRH
B. CDER
C. CFER
D. CVM ✔ Ans - C. CFER
What is the mission of the FDA? A. Promote public health B. Protect public health C. Pursue international harmonization D. All of the above ✔ Ans - D. All of the above
The Freedom of Information Act prohibits FDA from preventing the release of FDA-generated records: True or False ✔ Ans - FALSE
Veterinary drugs are regulated under the Center for Drug Evaluation and Research (CDER), because the requirements for approval are the same: True or False ✔ Ans - FALSE
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) ✔ Ans - D) Medical Device Amendments of 1976 (MDA)
In order of highest level to lowest level, the ranking at US governmental organizations is:
A. Division, Office, Center, Agency, Department
B. Department, Agency, Center, Office, Division
C. Center, Department, Division, Agency, Office
D. Agency, Center, Office, Department, Division ✔ Ans - B. Department, Agency, Center, Office, Division
Your company is developing a new drug to be developed and used in combination with a cystoscopic light device for the early detection of bladder cancer. You are asked to develop an overall regulatory strategy. The first step you undertake is:
A. Submit a Request for Designation to FDA Office of Combination Products for
determination of the lead center for primary jurisdiction for the combination product
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