https://www.lw.com/admin/upload/SiteAttachments/Recent-FDA-Guidan...

https://www.lw.com/admin/upload/SiteAttachments/Recent-FDA-Guidance-Signals-Increased-Willingness-to-Engage-Industry-Stakeholders.pdf

Conclusions
The Draft Guidance expands opportunities for industry to meet with FDA, reflecting the terms that FDA and
industry stakeholders agreed to during PDUFA VII negotiations. Specifically, the Draft Guidance provides
PDUFA sponsors and applicants with additional meeting types, reorganizes the formats of meetings, and
provides opportunities to ask clarifying questions when interacting with the Agency regarding a meeting. In
addition to these changes, FDA has also increased options for interaction between the Agency and other
stakeholders through recent updates to other draft and final guidance documents.


Chief medical officer perhaps got some clarification

The scenario below is fiction

Is the new potency data acceptable? Yes- it is sufficient- please refile your BLA


What are the chances that question was asked?


Reg