29 Questions
What is the primary objective of a regulatory affairs professional when developing the content for a Type B meeting with FDA?
Ensure content is sufficient to support meeting objective(s) and questions to FDA
Which of the following is a requirement for informed consent documentation?
Revised due to change in contact person name and/or phone number
Which scenario would not constitute misbranding?
Lack of NDC on label
What should be the initial action if you believe a combination product will be designated as a drug instead of a device based on its primary mode of action?
Seek FDA guidance on reclassification
What is a common rule that requires a minor change to a device and involves a joint review with the agency?
Real Time PMA Supplement
What is the written submission to OCP requesting designation of the center with primary jurisdiction for a combination or non-combination product?
RFD
Which regulation reauthorized key programs like PDUFA, MDUFMA, and PRE, and required registration of all clinical trials except phase I?
FDAAA
In the context of medical devices, what does B.eCTD stand for?
Transitional device
What is required for any display of written, printed or graphic matter on the immediate container or package of an article?
Label
Which regulation deals with premarket approval of medical devices?
21 CFR 814
'Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution' is regulated under which CFR?
21 CFR 207
Which division should a formal request for designation be submitted to?
Office of Combination Products
Which device would be regulated by CBER?
HIV diagnostic test kit
Regarding Establishment Registration, which statement is correct?
Foreign establishments are required to register.
Which regulation is NOT part of the requirements for conducting a human-use clinical device trial?
21 CFR 807 Establishment Registration
Which amendment is NOT typically required for a clinical protocol?
No amendment is ever required
What does the FDA order to delay proposed clinical investigation or suspend an ongoing investigation?
False
How do devices receive marketing permission through the 510(k) process?
By demonstrating substantial equivalence to a pre-amendment device
What is an Investigational New Drug Application (IND)?
A document for approval of marketing drugs
What is the study of the process of ADME of chemicals and medicines also known as?
Pharmacodynamics
Would a violative device cause serious adverse health consequences?
True
What are Orphan Drugs?
Drugs for rare diseases
What are Bioresearch Monitoring Programs responsible for monitoring?
Clinical trials and research studies
What type of fees are authorized by Congress to fund various FDA activities?
User fees
Which organization established ClinicalTrials.gov?
NIH
What is the maximum penalty that FDA can impose for false and misleading DTC advertisements under FDAAA?
$500,000
Which acronym stands for Absorption, Distribution, Metabolism, and Excretion in pharmaceuticals?
ADME
After reviewing a 510(k), which action can FDA NOT take?
Approve the device for market
What do ICH guidelines represent?
Joint opinions of the pharmaceutical industry and regulatory agencies in US, Europe, and Japan
Test your knowledge of FDA regulations with this quiz covering topics like clinical investigations, marketing permissions, and Investigational New Drug Applications.
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