Question

Which one of the following statements is NOT true with respect to both INDs and IDEs for significant-risk products?

A. The investigational product must be manufactured in full compliance with cGMP.
B. Clinical studies must be reviewed and approved by an Institutional Review Board.
C. The IND or IDE goes into effect 30 days after FDA receives the application, unless
FDA notifies the sponsor otherwise.
D. The application must include an environmental impact statement that contains a claim
for categorical exclusion or an environmental assessment.

Answer 1

The statement that is NOT true with respect to both INDs and IDEs for significant-risk products is D. The application must include an environmental impact statement that contains a claim for categorical exclusion or an environmental assessment.

Step-by-step explanation:

The statement that is NOT true with respect to both INDs and IDEs for significant-risk products is D. The application must include an environmental impact statement that contains a claim for categorical exclusion or an environmental assessment.

INDs (Investigational New Drug) and IDEs (Investigational Device Exemption) are regulatory mechanisms used by the FDA for reviewing and approving clinical studies of new drugs and medical devices, respectively. The other statements provided are true:

1. The investigational product must be manufactured in full compliance with cGMP (current Good Manufacturing Practice).
2. Clinical studies must be reviewed and approved by an Institutional Review Board.
3. The IND or IDE goes into effect 30 days after FDA receives the application unless FDA notifies the sponsor otherwise.