And speaking of PDUFA reauthorization – wait, time out.
FDA has proposed a new application review model that would allow it to call a time-out, which could be used to resolve mid-cycle issues.
The idea seems to be an admission by the agency that the six and ten month review times for priority and standard applications, respectively, are no longer sufficient to actually complete a review.
So, it’s not really an issue of “time out” as it is “time on” – as in “time added” at the agency’s discretion.
Minutes of the Sept. 27 industry and FDA Prescription Drug User Fee Act reauthorization negotiation revealed the agency proposed the time-out solution in an effort to create more application review time that will, among other things, allow more feedback to sponsors.
The proposal also could be used to address industry requests for a formal mid-cycle meeting to gain agency feedback on an application’s direction.
But will more feedback result in greater predictability? The length of the review clock stoppage would be fixed, but was not specified in the minutes of the 9/27 meeting.
Industry representatives called for a mid-cycle review in a previous PDUFA negotiating session, but FDA said comprehensive feedback likely was not possible at the midpoint of an application review because its process is not complete. Hm.
An agency willingness to add more meetings to the process is a change from previous discussions with industry, where the agency argued allowing for more meetings could lead to more sponsor questions and create more work for reviewers.
But FDA maintains its previous position that it cannot provide additional application support with the resources it has -- and so its offer for more sponsor-requested meetings means the review time must be extended. Hm.
