- FDA Issues Guidance on Meetings between Agency and Sponsors to Promote Consistency and Effectiveness
- April 22, 2015 | Author: Scott S. Liebman
- Law Firm: Loeb & Loeb LLP - Washington Office
- The agency is making recommendations on formal meetings about the development and review of drugs or biological products that fall under the regulation of the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) in a bid to provide consistent procedures promoting well-managed and effective meetings.
Every year, the FDA takes part in meetings requested by companies seeking advice about developing and reviewing investigational new drugs (INDs) and biologics or drug and biological product marketing applications. The meetings can be categorized into three types - A, B or C. The good meetings management practices (GMMPs) included in the guidance document are meant to provide consistent procedures that promote well-managed meetings and ensure that these are scheduled within a reasonable time, conducted efficiently and documented appropriately.
The guidance goes over the principles of GMMPs and explains standardized procedures for requesting, preparing, scheduling, conducting and documenting meetings. It was updated in accordance with the Prescription Drug User Fee Act (PDUFA) Reauthorization Performance Goals and Procedures FY 2013 through 2017, and revises the 2009-issued Formal Meetings Between the FDA and Sponsors or Applicants. Among noteworthy amendments were the addition of a written response meeting format for pre-IND applications and Type C meetings, the addition of a meeting package in Type A meeting requests, and the designation as a Type B meeting about risk evaluation and mitigation strategies or post-marketing requirements occurring beyond the context of the review of a marketing application, among others.
Specifically, the document lays out the FDA’s expectations regarding meeting requests, including how they should be submitted and what information should be included, and goes over its process for evaluating requests, including what happens when a meeting is denied or granted. Requesters are advised to include 13 pieces of information when requesting a meeting, including its purpose and objective, a proposed agenda and list of questions, and the meeting type - even though the CBER or the CDER will ultimately determine this. Companies requesting type A meetings can expect a response within 14 days of receipt, while those requesting types B and C meetings will receive a response within 21 days.
Examples of circumstances under which companies should reschedule or cancel are also provided. The FDA recommends that companies reschedule when the submission of a meeting package is delayed or a critical attendee can no longer attend at the scheduled time, and cancel when the package isn’t received in the specified time frame or it’s totally inadequate.
The document also provides guidance on meeting packages, including the timing of submissions per meeting type, and where and how many copies should be sent. The FDA lists 11 key pieces of information that the meeting package should contain, and advises companies to organize the package in accordance with the proposed agenda. The guidance advises companies to include summary information about the product as well as the results of relevant studies and trials, specifying that the description of a result as “significant” is inadequate. The document also notes that the whole package content must support the meeting’s objective, and finishes by covering pre-meetings and communications, meeting conduct and documentation, and resolution of disputes regarding meeting minutes.