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Questions and Answers
Which regulatory document is discussed in the text?
Which regulatory document is discussed in the text?
- Regulatory & Compliance Issues
- Investigational New Drug (IND) Application (correct)
- Fall 2023
- Expanded Access Studies
What is the purpose of an Investigational New Drug (IND) Application?
What is the purpose of an Investigational New Drug (IND) Application?
- To provide information needed for clinical studies
- To introduce a new drug into interstate commerce
- To determine the reasonable risk of the new drug and proposed study (correct)
- To request exemption from the FD&C Act's prohibition
Who is responsible for submitting an Investigational New Drug (IND) Application?
Who is responsible for submitting an Investigational New Drug (IND) Application?
- Sponsor-Investigator
- FDA
- Sponsor Entity (correct)
- Study Subjects
What is the main focus of Expanded Access Studies?
What is the main focus of Expanded Access Studies?
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What does the Sponsor-Investigator specifically request in an Investigational New Drug (IND) Application?
What does the Sponsor-Investigator specifically request in an Investigational New Drug (IND) Application?
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