All RAC Practice Exam QuestionsSolutions

All RAC Practice Exam – Questions/Solutions According 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:

• The dates and results of the investigation
• The nature and details of the complaint
• Changes in procedures correcting quality problems
• 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 list of all components used in the manufacture of the investigational drug

product

• A statement of compliance with applicable GMPs
• Statistical methods to be used in the analysis of phase II and III clinical trials
• 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?

• Advisory Committee meetings can include an oral presentation from a

patient advocacy group.

• Advisory Committee members are selected without regard to race,

ethnicity, sex, age or religion. 1 / 4

• Advisory Committees provide advice to FDA on safety and effectiveness of

drugs.

• Advisory Committees recommend whether a drug should be approved and

do not provide advice on product labeling or clinical trial design. ✔️Ans -

• 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:

• Focus on labeling and marketing since mutual recognition does not require

complete technical review

• Include R&D production, marketing, QA and clinical research for a thorough

review

• Summarize financial data and distribution data which are normally

required to be submitted to FDA

• 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:

• Write a letter to FDA requesting a Type A meeting as an amendment to the

IND

• Request a Type B meeting as an amendment to the IND
• Call the project manager and set up a date over the phone for a Type C

meeting

• 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 2 / 4

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

• The Pure Food and Drug Act
• The Federal Food Drug and Cosmetic Act
• The Kefauver-Harris Drug Amendments
• 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)?

• Generic drugs only
• Orphan drugs and cosmetics only
• OTC drugs, cosmetics, generic drugs and medical devices
• Prescription drugs marketed before 1992 ✔️Ans - C. OTC drugs,

cosmetics, generic drugs and medical devices

MDUFMA is an acronym for:

• Managing Department for the Unification of Foreign Medicinal Applications
• Medical Device Users Fee and Modernization Act
• Modernization of Devices Used for Medical Anomalies
• 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

• CVM ✔️Ans - C. CFER

What is the mission of the FDA? 3 / 4

• Promote public health
• Protect public health
• Pursue international harmonization
• 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?

• Safe Medical Devices Act of 1990 (SMDA)
• Medical Device User Fee and Modernization Act of 2002 (MDUFMA)
• Federal Food, Drug, Cosmetic Act (FDC Act)
• 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:

• Division, Office, Center, Agency, Department
• Department, Agency, Center, Office, Division
• Center, Department, Division, Agency, Office
• 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:

• Submit a Request for Designation to FDA Office of Combination Products for

determination of the lead center for primary jurisdiction for the combination product

• / 4