Quiz: Investigational New Drugs

1. An investigational drug cannot be a controlled substance.
A. TRUE
B. FALSE

2. The sponsor must wait how many calendar days after IND submission in support of an Investigational New Drug application (IND)?
A. 7
B. 15
C. 30
D. 60

3. If a protocol change is needed to eliminate an apparent immediate hazard, it should only be implemented after:
A. Notifying the FDA via a protocol amendment.
B. Notifying the IRB.
C. Both A and B.

Investigational New Drug Applications require non-clinical studies before clinical investigations. Protocol changes should be communicated to the FDA and IRB for implementation.

Explanation:

Investigational New Drug Applications (IND) require completion of non-clinical laboratory studies before clinical investigations can commence. The IND application includes data from animal testing, drug composition details, and the investigational plan.

Changes to protocols during clinical development must be communicated to the FDA via a protocol amendment. This ensures that any new findings or risks are properly addressed to maintain participant safety.

If a protocol change is necessary due to an apparent issue, it should be implemented after notifying the FDA via a protocol amendment and the Institutional Review Board (IRB) for proper oversight.

Learn more about Investigational New Drug Applications (IND) here:

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