PDUFA VI - Some thoughts
At the end of 2017, PDUFA V expires, so the FDA is currently looking at options in PDUFA VI. It will be vital to understand these proposals when planning for the future, especially as some may fundamentally change FDA procedures.
One of the these changes, will potentially be very beneficial. According to the FDA, the FDA and drug sponsor will have the option to agree on a Formal Communication Plan during application review that may or may not include Program elements (e.g., late-cycle meetings) and interactions that are not part of the Program (e.g., application orientation meetings). This will help in planning for the various Pharmaceutical and Biotech companies looking to have their meetings more codified by the FDA. On the Manufacturing end, applications submitted under the current PDUFA V already need to contain a list of all manufacturing site. However, if your list is deficient, the FDA has said that as part of PDUFA VI, it can extend the goal date to accommodate this unexpected inspection.
On a positive note, the FDA will be implementing Type B(EOP) meetings. These will be specific meetings for the End Of Phase X, and as part of this, it will also be changing the time frames for Type C meetings. The FDA wants to engage with companies, and this is a step toward that end. There is a great deal more to PDUFA VI, and at the end of the day, your regulatory group will need to understand it in detail to be able to guide you through. Always consider that there are consultants willing to help you understand the ins and outs of PDUFA VI, and how it will effect your company.
