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Questions and Answers
What is the primary objective of a regulatory affairs professional when developing the content for a Type B meeting with FDA?
What is the primary objective of a regulatory affairs professional when developing the content for a Type B meeting with FDA?
- Provide appropriate clinical summary
- Ensure content is sufficient to support meeting objective(s) and questions to FDA (correct)
- Reach consensus on content from contributing team members
- Provide appropriate preclinical summary
Which of the following is a requirement for informed consent documentation?
Which of the following is a requirement for informed consent documentation?
- Revised due to new information regarding the investigational product that might affect a subject's willingness to participate in the study becomes available
- Revised due to change in contact person name and/or phone number (correct)
- Approved by the clinical trial site IRB
- Signature of the subject or the subject's legal representative
Which scenario would not constitute misbranding?
Which scenario would not constitute misbranding?
- Lack of NDC on label (correct)
- A drug product without a manufacturer, packer or distributor on the label
- An incorrect lot number on the label
- Font size of established name is 25% of the font size of the trade name
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?
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?
What is a common rule that requires a minor change to a device and involves a joint review with the agency?
What is a common rule that requires a minor change to a device and involves a joint review with the agency?
What is the written submission to OCP requesting designation of the center with primary jurisdiction for a combination or non-combination product?
What is the written submission to OCP requesting designation of the center with primary jurisdiction for a combination or non-combination product?
Which regulation reauthorized key programs like PDUFA, MDUFMA, and PRE, and required registration of all clinical trials except phase I?
Which regulation reauthorized key programs like PDUFA, MDUFMA, and PRE, and required registration of all clinical trials except phase I?
In the context of medical devices, what does B.eCTD stand for?
In the context of medical devices, what does B.eCTD stand for?
What is required for any display of written, printed or graphic matter on the immediate container or package of an article?
What is required for any display of written, printed or graphic matter on the immediate container or package of an article?
Which regulation deals with premarket approval of medical devices?
Which regulation deals with premarket approval of medical devices?
'Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution' is regulated under which CFR?
'Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution' is regulated under which CFR?
Which division should a formal request for designation be submitted to?
Which division should a formal request for designation be submitted to?
Which device would be regulated by CBER?
Which device would be regulated by CBER?
Regarding Establishment Registration, which statement is correct?
Regarding Establishment Registration, which statement is correct?
Which regulation is NOT part of the requirements for conducting a human-use clinical device trial?
Which regulation is NOT part of the requirements for conducting a human-use clinical device trial?
Which amendment is NOT typically required for a clinical protocol?
Which amendment is NOT typically required for a clinical protocol?
What does the FDA order to delay proposed clinical investigation or suspend an ongoing investigation?
What does the FDA order to delay proposed clinical investigation or suspend an ongoing investigation?
How do devices receive marketing permission through the 510(k) process?
How do devices receive marketing permission through the 510(k) process?
What is an Investigational New Drug Application (IND)?
What is an Investigational New Drug Application (IND)?
What is the study of the process of ADME of chemicals and medicines also known as?
What is the study of the process of ADME of chemicals and medicines also known as?
Would a violative device cause serious adverse health consequences?
Would a violative device cause serious adverse health consequences?
What are Orphan Drugs?
What are Orphan Drugs?
What are Bioresearch Monitoring Programs responsible for monitoring?
What are Bioresearch Monitoring Programs responsible for monitoring?
What type of fees are authorized by Congress to fund various FDA activities?
What type of fees are authorized by Congress to fund various FDA activities?
Which organization established ClinicalTrials.gov?
Which organization established ClinicalTrials.gov?
What is the maximum penalty that FDA can impose for false and misleading DTC advertisements under FDAAA?
What is the maximum penalty that FDA can impose for false and misleading DTC advertisements under FDAAA?
Which acronym stands for Absorption, Distribution, Metabolism, and Excretion in pharmaceuticals?
Which acronym stands for Absorption, Distribution, Metabolism, and Excretion in pharmaceuticals?
After reviewing a 510(k), which action can FDA NOT take?
After reviewing a 510(k), which action can FDA NOT take?
What do ICH guidelines represent?
What do ICH guidelines represent?
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