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FDA presenter: clarification requests limited to original submissions; be careful with waiver requests
Summary
The presenter said clarification requests must be based on the original submission (new information cannot be added) and cautioned applicants about waiver requests (for example, BCS Class III). She also provided portal-entry tips for applicants and US agents.
The presenter explained limits on clarification requests: “In a clarification of ambiguity request, you may ask FDA to review the new or additional information, as well as ask follow-up questions of the agency's response. That's false. So the agency will clarify the response, but it will be based on what you originally submitted in your original submission, not with consideration of new information or clarification from your point of view.”
She also warned applicants to be careful with waiver requests and highlighted portal tips: select the correct reference listed drug, ensure the company name in documents matches the portal, and use distinct points of contact for an applicant and U.S. agent. Foreign applicants must utilize a U.S. agent and letters of authorization are valid for one year and must be uploaded with the control correspondence.
