💊FDA Reopens Comment Period on Prescription Drug User Fee Act VII
Prescription Drug User Fee Act VII; Independent Assessment of Communication Through Product Quality Information Requests During Application Review; Final Report; Availability; Reopening of Comment Period
Summary
The Food and Drug Administration (FDA or the Agency) is reopening the comment period for the notice of availability entitled "Prescription Drug User Fee Act VII; Independent Assessment of Communication Through Product Quality Information Requests During Application Review; Final Report; Availability; Request for Comments" that appeared in the Federal Register of May 9, 2025. In the notice of availability, FDA requested comments on the final assessment report. The Agency is taking this action in response to a request to allow interested persons additional time to submit comments.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$ - Med
The reopening of the comment period allows stakeholders greater input into the FDA's assessment of communication related to product quality information. This can impact compliance and regulatory strategies for businesses affected by these reviews, particularly in the pharmaceuticals sector.