RAC-US ALL PRACTICE EXAM FINAL
QUESTIONS & CORRECT ANSWERS
PASSED ALREADY GRADED A+
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 - correct answer
✔✔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.
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 - correct answer ✔✔C. OTC drugs, cosmetics,
generic drugs and medical devices
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:
,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 - correct answer ✔✔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.
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 - correct answer ✔✔B. The Federal Food Drug and Cosmetic
Act
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 - correct answer ✔✔B. Medical
Device Users Fee and Modernization Act
Which is not a division of the FDA?
,A. CDRH
B. CDER
C. CFER
D. CVM - correct answer ✔✔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 - correct answer ✔✔D. All of the above
The Freedom of Information Act prohibits FDA from preventing the release of FDA-generated
records:
True or False - correct answer ✔✔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 - correct answer ✔✔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) - correct answer ✔✔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 - correct answer ✔✔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
B.Make a preliminary internal company determination of the combination product's primary
mode of action
C. Submit an IND along with a Request for Designation to FDA CDER Office of Oncology Drug
Products (OODP)
D. Submit a request for designation to FDA CDRH and notify the Office of Combination Products
- correct answer ✔✔B.Make a preliminary internal company determination of the combination
product's primary mode of action
For nonclinical studies lasting more than 6 months, quality assurance audits are conducted at
which of the following intervals?
A. 1 month
QUESTIONS & CORRECT ANSWERS
PASSED ALREADY GRADED A+
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 - correct answer
✔✔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.
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 - correct answer ✔✔C. OTC drugs, cosmetics,
generic drugs and medical devices
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:
,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 - correct answer ✔✔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.
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 - correct answer ✔✔B. The Federal Food Drug and Cosmetic
Act
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 - correct answer ✔✔B. Medical
Device Users Fee and Modernization Act
Which is not a division of the FDA?
,A. CDRH
B. CDER
C. CFER
D. CVM - correct answer ✔✔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 - correct answer ✔✔D. All of the above
The Freedom of Information Act prohibits FDA from preventing the release of FDA-generated
records:
True or False - correct answer ✔✔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 - correct answer ✔✔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) - correct answer ✔✔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 - correct answer ✔✔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
B.Make a preliminary internal company determination of the combination product's primary
mode of action
C. Submit an IND along with a Request for Designation to FDA CDER Office of Oncology Drug
Products (OODP)
D. Submit a request for designation to FDA CDRH and notify the Office of Combination Products
- correct answer ✔✔B.Make a preliminary internal company determination of the combination
product's primary mode of action
For nonclinical studies lasting more than 6 months, quality assurance audits are conducted at
which of the following intervals?
A. 1 month
