Regulatory Assessment #1
Regulatory Affairs Assessment Quiz
Test your knowledge on regulatory affairs with our comprehensive quiz designed for professionals in the field. Explore a variety of questions that cover key concepts, regulations, and the history of the FDA.
- 51 challenging questions
- Multiple-choice format
- Immediate feedback on your answers
What does a regulatory affairs professional do?
Work with the FDA and other regulatory authorities
Help get drugs approved by the FDA
Keep dietary supplements safe for use by creating reliable quality systems for manufacturing and distribution
All of the above
What does the FDA do?
Protect the public from electronic product radiation
Make life harder for medical product companies
Keep medical devices from being used
All of the above
What does the acronym FDA stand for?
Facebook Display of Affection
Food and Drug Administration
Free Dominos Always
Food Delivery App
An X-Ray machine meets the definition of:
A medical Device
A biologic
A drug
A dietary supplement
Who regulates packed red blood cells (RBCs) intended for human infusion
CDER
CDRH
CFSAN
CBER
Which is the lowest risk classification for a medical device?
Class I
Class II
Class III
OTC
The regulatory chronology of medical product development is:
GMP, GCP, GLP, Post-Market Requirements, Pre-Market Application
GCP, GLP, GMP, Post-Market Requirements, Pre-Market Application
GLP, GMP, GCP, Pre-Market Applications, Post-Market Requirements
Pre-Market Applications, GLP, GMP, GCP, Post-Market Requirements
FDA considers Harvey Wiley and Frances Kelsey to be heroes in protecting public health.
True
False
When the FDA refers to "The Act" they are referring to which law, because of the sulfanilamide tragedy?
Food, Drug, and Cosmetic Act of 1938
Penicillin Amendment of 1945
Kefauver-Harris Amendment of 1962
FDAMA of 1997
FDA resides within the HHS public health service division
True
False
FDA's operating budget is approved by the Supreme Court
True
False
FDA's authority may:
Overlap with other agencies
Be complementary to other agencies
Be in conflict with other agencies
All of the above
Who regulates medical devices intended for human use?
CDER
CBER
CDRH
CFSAN
ISO-10993 is the FDA-recognized biocompatibility standard for medical devices
True
False
The lower the risk to the patient, the less biocompatibility testing is required to support an IDE or IND submission
True
False
Biocompatibility studies for drugs should be GLP compliant, and if they are not GLP compliant, a justification should be provided to FDA in the IND and NDA
True
False
Who conducts BIMO inspections?
HHS
EPA
USDA
FDA
Not on assessment she just "threw this out there".....Who conducts IACUC inspections?
HHS
EPA
USDA
FDA
GMP documentation is:
Unlikely to influence the outcome of an FDA inspection
Not a regulatory requirement
The backbone of a quality system
Likely to increase liability exposure, so do not document anything
FDA's mantra is "If it was not documented, you can verbally explain what happened"
True
False
Elements of GDP include:
Using pencils to record data
Covering any mistakes with white-out
Information can be recorded onto a post-it note initially and be transferred into a lab notebook at a later date
Prompt recording of all data collected
A phase 2 drug clinical trial is:
Intended to evaluate initial effectiveness and determine dosages for the phase 3 study
A first in man study
Intended to confirm safety and efficacy and to collect data for inclusion in the final package insert
To collect additional data on a subpopulation
Nonclinical studies are In Vitro studies intended to support an IDE or IND submission
True
False
A cost savings clinical study would be a:
Phase 1
Phase 2
Phase 3
Phase 4
New medical product approvals only happen with substantial evidence from adequate and well-controlled trials
True
False
Features of a well-controlled study include:
Protocol contains clear statement of study objectives
The study report provides sufficient details of study design, conduct, and analysis
Adequate measures were used to minimize bias to subjects, observers, and data analyzers
All of the above
All medical device clinical trials require an IDE submission
True
False
FDA has 60 days to review an IND and provide feedback to the sponsor
True
False
Elements of a GCP compliance study include:
Medical care for a subject may be withheld if the care could introduce variability into the study
Study is conducted in accordance with the Declaration of Helsinki
The investigational medical product is freely available to be used by anyone in the workplace
All of the above
An IRB must be composed of:
15 scientists
Only women
At least one person who is not employed or has a vested interest in the institution
All of the above
When filing an IND, the clinical study must be registered with the clinicaltrials.gov
True
False
When a drug manufacturer wants to convert their prescription drug to OTC intended use, they must file which pre market submission with FDA?
NDA
ANDA
De Novo
BLA
The acronym CMC stands for:
Carboxymethylcellulose
Center for Medical Careers
Crisis Management Committee
Chemistry, Manufacturing, and Controls
How long does FDA have to review a standard NDA?
90 days
18 months
10 months
30 days
When a manufacturer wants to market a biologic product, which pre-market submission must they file with FDA?
NDA
ANDA
PMA
BLA
What are the benefits of a CTD?
More consistent reviews
Easier exchange of information
Facilitate electronic submissions
All of the above
One key difference between an ANDA and an NDA is that an ANDA requires bioequivalence data
True
False
An orphan drug is only approved to treat a disease or condition with less than 8,000 patients in the U.S.
True
False
A BLA and NDA are similar in overall content
True
False
A 351k application must include data demonstrating biosimilarity
True
False
A list of licensed biological products with reference product exclusivity and biosimilarity or interchangeability evaluations can be found where?
Purple Book
Red Book
Orange Book
Yellow Book
What is an example of a medical device general control?
Consensus standard
Guidance document
Establishment registration and device listing
Post-market study commitments
What is an example of a medical device special control?
Consensus standard
Compliance to labeling regulations
Compliance to the QSR
Submission of 510(k)
IDE medical devices must be labeled as IUO (investigation use only)
True
False
The term "substantial equivalence" is related to which type of FDA submission?
ANDA
510(k)
PMA
De Novo
Which year was P212023 filed with FDA?
2023
2021
2020
2012
Which document is submitted within a 510(k)?
Manufacturing information
Summary of safety and effectiveness data
Class III summary and certification
CMC details
Which FDA submission requires an annual report?
510(k)
De Novo
QSR
PMA
In an RFD submission the sponsor must describe the primary mode of action of the medical product
True
False
EUAs never expire
True
False
Who regulates dietary supplement advertising
DEA
FDA
FTC
USDA
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