Which of the following is an acceptable criterion for determining that a study of an approved drug does not require an IND?
The study is not intended to be reported to FDA to support a new indication or support a labeling change.
The number of subjects in a study is not a consideration for IND exemption. Any study that significantly increases risk to subjects or invokes an exception from informed consent for emergency research (21 CFR 50.24) does not meet one of the criterion for an IND exemption. Investigations that are not intended to be reported to FDA do qualify as meeting one of the six required conditions for an IND exemption.

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13-12-2022
Social Studies

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Which of the following is an acceptable criterion for determining that a study of an approved drug does not require an IND?
The study is not intended to be reported to FDA to support a new indication or support a labeling change.
The number of subjects in a study is not a consideration for IND exemption. Any study that significantly increases risk to subjects or invokes an exception from informed consent for emergency research (21 CFR 50.24) does not meet one of the criterion for an IND exemption. Investigations that are not intended to be reported to FDA do qualify as meeting one of the six required conditions for an IND exemption.

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topeadeniran2 topeadeniran2 · Answer 1 · 2022-12-16T12:53:38+01:00

The option that is not an acceptable criterion for determining that a study of an approved drug does not require an IND is A. The study is not intended to be reported to FDA to support a new indication or support a labeling change.

What is the illustration about?

The study isn't meant to be submitted to the FDA as evidence in support of a brand-new indication or a labeling modification.

A study's subject count is not taken into account when determining whether to grant an IND exemption. Any study that violates the 21 CFR 50.24 exception from informed consent for emergency research or significantly raises the risk to subjects does not satisfy one of the requirements for an IND exemption. Investigations with no intention of reporting results to the FDA do meet one of the six prerequisites for an IND exemption.

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