How to Meet FDA: New Guidance Formalizes Well Know Common Sense 
​​[Posted on: Thursday, January 11, 2018]

FDA released a new guidance to describe the current process for arranging meetings with the review divisions in CDER ad CBER combining and simplifying information from previous guidance documents, updating some critical timelines and retiring the old defunct guidance documents on the same topic. In the last decade, FDA’s management carried out a major publicity campaign to encourage regulated companies to meet the reviewers more often to discuss applications. FDA officials made numerous presentations at all major industry conferences touting the value of meeting regulators at various times in the development stages of new products. And the campaign bore fruit in terms of increased number of meetings between FDA and developers, and increased number of first-cycle approvals. FDA also introduced several new kinds of meetings to address specific products such as breakthrough therapy designated products, and biosimilar products. At the same time, the process to request meetings with FDAs Centers from drugs, biologics, and medical devices evolved into a significant project management enterprise for the FDA and industry alike. Two guidance documents describing the process to arrange meetings with FDA, one released in 2009 and another in 2015 quickly became hard to follow due to the volume of meeting requests and tighter time commitments by the FDA. Last month, FDA released a new guidance document updating the rules for requesting meetings with the FDA; the old guidance documents from 2009 and 2015 were withdrawn at the same time. This new guidance applies only to meetings with CDER and CBER. The process for requesting the meetings and the logistics have remained mostly unchanged. The major revision is in the timeline commitments and formalization of the process to provide Written Responses Only (WRO) in lieu of having a live meeting. FDA also clarified what kinds of meetings are more or less likely to be granted; Type A and C meetings are less likely while Type B meetings are more likely to be granted. Further Type B meetings are now classified into two sub-groups; the Type B and the Type B (End of Phase, EOP) meeting. The only difference between the Type B and B(EOP) is the duration of time needed to review the meeting information package and the expected time to received the preliminary comments. These instructions should not be very surprising for any company that has arranged a meeting with FDA in the last 2-3 years. Also, the fact that Type A and C meetings are the hardest to get should not be news to most companies with experience requesting such meetings. The guidance is much more precise than its predecessors and should reduce errors while also setting realistic expectations from meetings with FDA.