Reasoning: Action 4
If a general question about an existing policy, regulation, or the regulatory process is submitted to any of the email addresses specified below, whenever practicable, FDA should provide a response within 5 business days or acknowledge receipt of the inquiry and provide an approximate timeframe for response. This will be tracked on FDA-TRACK.
It is important to provide clear expectations to industry, which includes a time frame for response to general questions about the regulatory process submitted to the agency. The recently instituted standardized email addresses for industry are as follows:
As mentioned above, the addition of these standardized email addresses does not disrupt the functionality of other email addresses that accepted questions from industry in the past.
The Task Force concluded that questions submitted by applicants or sponsors about specific applications under review by the agency are best handled through the product review process. Product application review may involve complex issues of science and the Task Force concluded that those questions are best handled on a case-by-case basis.