By Benjamin Policicchio, PhD and Suzanne M. Sensabaugh, MS, MBA
In December 2017, the FDA published an update to the 2009 “Formal Meetings Between the FDA and Sponsors of Applicants” to detail new information for sponsors of Prescription Drug User Fee Act (PDUFA) products. At the time of publication, two previous guidances of the same topics were withdrawn, one from 2009 and the other from 2015.
Despite 8 years separating the 2009 guidance and the current one, there are relatively few changes. This may reflect the overall maturity of the PDUFA program, as this is the fifth iteration. As in the 2009 version, this guidance addresses meetings related to the development and review of drug or biological drug products. Note, however, this guidance does not apply to abbreviated new drug applications, applications for biosimilar biological products, or medical devices. Below, we will discuss the major changes in this new guidance.
Meeting Types and Formats
- There are now four defined meeting types: Type A, Type B, Type B (end-of-phase [EOP]), and Type C.
- The Type B (EOP) represents a break-off from the 2009 Type B meeting and consists of end-of-phase 2 meetings, pre-phase 3 meetings, and certain end-of-phase 1 meetings.
- Type C meetings can be used to facilitate early consultations on the use of a biomarker as a new surrogate endpoint to be used as the primary basis for approval.
- Three meeting formats for the meeting types have been introduced: Face to face; Teleconference/Videoconference; Written response only.
Meeting Requests and Packages
- More details about what to include in the meeting request and package are defined, including both essential and suggested information.
- Several new details include:
- The proposed regulatory pathway (e.g., 505(b)(1), 505(b)(2));
- Pediatric study plans (if applicable);
- Human factors engineering plan (if applicable);
- Combination product information (if applicable);
Formal Meetings Timelines
Several updates to timelines associated with meetings are included in the current guidance. In the table below, changes to these timelines are in underline.
Meeting Scheduling, Minutes and Other
- FDA now states that the meeting date should be established within 14 calendar days of the requested date, if the requested date is beyond 30/60/70/75 days from the date of the request receipt.
- More detail regarding the content of meeting minutes has been included.
- Desk copies of meeting packages are to be sent for meetings with the CDER, but are not needed for meetings with the CBER.
The 2017 PDUFA formal meetings guidance is important for all sponsors considering a meeting with the FDA. Adherence to the information within this guidance will help sponsors have an efficient, beneficial meeting.
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Suzanne M. Sensabaugh has advanced the development of over 130 biologics, biosimilars, and combination products since 2009. She can be reached at firstname.lastname@example.org