This is what IMGG has been preparing 9 months for
A 2 hour meeting! And it's not like this dead horse hasn't been beaten already by IMGG and the FDA for the last 3 years.
But still, Dean needs a few more weeks to request this 2 hour meeting.
Agreement Meeting
Applicant Activities
Meeting Preparation
Contact the appropriate branch to have a general discussion regarding the device.
A request for an Agreement Meeting should be: a) clearly identified as such and b) submitted in triplicate to the Document Mail Center (HFZ-401). The submission should include the information described above for Determination Meetings as well as the clinical protocol. Any particular items upon which agreement is to be reached should be clearly identified. These items may include:
Sample Size, including a statistical justification
Inclusion/Exclusion Criteria
Endpoints (Primary and Secondary with acceptance/failure criteria)
Overall study success criteria including justification
Study duration
Number of study sites
Data Monitoring Committee (DMC) operations (these are also sometimes called Data and Safety Monitoring Boards (DSMBs))
Planned statistical analysis
Special informed consent provisions, e.g., waivers
The Agency expects that the submission should be approximately 10-20 pages in length.
Arrange for a preliminary meeting (videoconference or teleconference) to review the submitted information and to identify key issues that the applicant wishes to reach agreement on with the Agency. It is critical that the applicant be as specific as possible (e.g., sample size) in identifying the issues for agreement. Identifying broad concepts (e.g., the clinical protocol) may make reaching an agreement more difficult given the number of variables that would need to be addressed. Finally, the applicant should determine if any additional information needs to be submitted prior to the actual Agreement Meeting.
Submit additional information, as required, and provide a list of acceptable dates and times for the formal Agreement Meeting.
The Meeting
Meetings may be face-to-face, by videoconference, or by teleconference and should be scheduled for approximately 1-2 hours. It is important to note that the meeting format will generally be different for a pre-meeting than for the formal meeting. At a pre-meeting, the applicant should present and discuss the material submitted to the Agency. The Agency attendees should raise any questions for the applicant and request any additional information to be submitted prior to the formal meeting. Finally, the key issues on which agreement is to be reached should be identified by the applicant. At the formal meeting, the discussion should be focused on these key issues, hopefully, resulting in a number of areas of agreement.
Post-Meeting
The applicant should draft meeting minutes and exchange these with the Agency for review/comment within 7 days following the meeting.
The applicant may wish to complete the checklist entitled, "The Sponsor’s Evaluation of the Application of the Least Burdensome Principles in Early Collaboration Meetings." This checklist will be used by the Agency to help assess the industry’s satisfaction with FDA’s application of the least burdensome approach in its discussion of clinical trial design issues during the Agreement Meeting. The form may be found in Appendix B, and, once completed, it may be faxed to Ms.Wanda Sawyer-Major, Program Operations Staff at (301) 594-2977 at anytime.
Agency Activities
Meeting Preparation
A request for an Agreement Meeting will be logged in as a pre-IDE for tracking purposes (flagged as an agreement meeting request) and assigned a number (e.g., I000001). Within 7 days of receipt, the team leader for the submission should contact the applicant to establish dates for pre-meeting(s) and the formal Agreement Meeting. As specified in §520(g)(7)(A), the formal Agreement Meeting should occur within 30 days of receipt of the request. It is strongly recommended, however, that a mutually agreed-upon timeline be established to increase the probability of a successful meeting. Therefore, the applicant may request deferral of the formal meeting until one or more informal pre-meetings is completed.
The review division will decide which FDA staff should attend the meeting, but may include persons specifically requested by the applicant. The attendees may include: the team leader/project manager, medical officer, statistician, other scientists with expertise in the product area (from ODE, OC, OSB and/or OST), the appropriate branch chief, a division associate, deputy or director and a member of the POS. For meetings likely to consider novel products, development strategies, or controversial issues, the division should discuss the issue with, and if appropriate, include the participation of the Director or Deputy Director of ODE.
FDA should conduct an internal pre-meeting (more than one may be necessary) to ensure that everyone is familiar with the issues. In accordance with "The Systems Approach,"2 this meeting should also be used to consider our knowledge of and experience with similar products and to formulate FDA’s overall strategy for addressing the situation. A member of POS should be invited to the internal pre-meeting to provide background information on similar issues faced by other divisions and to offer guidance on any unique or controversial regulatory issues raised by the applicant’s request. The attendees should identify questions and issues to be discussed with the applicant. The timeline for any pre-meetings and the formal meeting with the applicant should also be discussed.
The Meeting
See the section with this title on the previous page.
Post-Meeting
At the end of the meeting, the Agency team leader for the application will summarize the agreements or explain any arrangements for tabling certain issues, including the date of the next meeting, if appropriate. A record of attendees and minutes of the meeting should be kept by both a designated FDA and applicant attendee. A laptop computer may be helpful in recording the issues discussed and any agreements that have been reached. The FDA applicant should exchange their respective meeting minutes for review following the meeting. This exchange may occur electronically for efficiency. The minutes should be in sufficient detail to reflect the substance of the issues discussed at the meeting; a bulleted format may be helpful.
The team leader should prepare the memorandum of agreement. POS will work with the team leader and review division to develop the memorandum and, in so doing, help to ensure that it accurately reflects the outcome of the meeting and is consistent with Office policy. Within two weeks of the meeting, a draft of the memorandum should be circulated for review among the FDA participants. The memorandum will then be signed by the Division Director and conveyed to the applicant within 30 days of the meeting. In addition, the Agency team leader should complete the checklist entitled, "FDA’s Evaluation of the Application of the Least Burdensome Principles in Early Collaboration Meetings." This checklist can be found in Appendix A of this document and is intended to be used to evaluate whether the least burdensome principles were considered in reaching the agreement. A copy of the memorandum and checklist should be placed in the document jacket, and the pre-IDE should be logged out by the division and POS.
Appendix A
FDA’s Evaluation of the Application of the Least Burdensome Principles
in Early Collaboration Meetings
Type of Meeting:
___ Determination Meeting §513(a)(3)(D)
___ Agreement Meeting §520(g)(7)
Division/Branch: ______________________________________________________
Application Number: ___________________________________________________
Sponsor: ____________________________________________________________
Device: _____________________________________________________________
In the early collaboration meeting with the sponsor, were the Least Burdensome principles applied in:
Determining the Need for Prospective Clinical Data?
Was pre-clinical testing considered in lieu of clinical data?
___ Yes ___ No
Explain: _______________________________________________________________ _____________________________________________________________________
Was the use of previously collected non-U.S. data, literature, and/or registry data considered?
___ Yes ___ No
Explain:_______________________________________________________________ _____________________________________________________________________
Designing the Clinical Trial?
Were alternatives to an actively controlled trial considered?
___ Yes ___ No
If yes, check the following:
i. Literature control ___Yes ___ No
ii. Historical control ___ Yes ___ No
iii. Non-active control ___ Yes ___ No
iv. Patient as their own control ___ Yes ___ No
v. Objective Performance Criteria ___ Yes ___ No
vi. Other ___ Yes ___ No
If other, describe: ___________________________________________________________
If alternatives could not be used, explain:__________________________________________
_________________________________________________________________________
Was the use of surrogate endpoints considered?
___ Yes ___ No
Explain: ________________________________________________________________
________________________________________________________________________
Was a least burdensome approach considered in determining how the primary and secondary endpoints will be measured?
___ Yes ___ No
Explain: ________________________________________________________________
_______________________________________________________________________
Was early submission of the application considered? That is, could the application be submitted after a mutually agreed to percentage of the patients had been followed for a pre-defined period of time?
___ Yes ___ No
Explain:_________________________________________________________________
________________________________________________________________________
Was the role of postmarketing information considered as a mechanism of reducing the premarket requirements?
___ Yes ___ No
Explain:_________________________________________________________________
________________________________________________________________________
Were the least burdensome principles applied in other areas of the trial design not mentioned above?
___ Yes ___ No
If yes, describe: _____________________________________________________________
___________________________________________________________________________
___________________________________________________________________________
___________________________________________________________________________
___________________________________________________________________________
____________________________________________
Team Leader signature Date
Appendix B
Sponsor’s Evaluation of the Application of the Least Burdensome Principles
in Early Collaboration Meetings
Type of Meeting:
___ Determination Meeting §513(a)(3)(D)
___ Agreement Meeting §520(g)(7)
Division/Branch:________________________________________________________
Application Number:_____________________________________________________
Sponsor:_______________________________________________________________
Device:_________________________________________________________________
In the early collaboration meeting with the sponsor, were the Least Burdensome principles applied in:
Determining the Need for Prospective Clinical Data?
Was pre-clinical testing considered in lieu of clinical data?
___ Yes ___ No
Explain: ________________________________________________________________ __________________________________________________________________________
Was the use of previously collected non-U.S. data, literature, and/or registry data considered?
___ Yes ___ No
Explain: ________________________________________________________________
________________________________________________________________
Designing the Clinical Trial?
Were alternatives to an actively controlled trial considered?
___ Yes ___ No
If yes, check the following:
i. Literature control ___ Yes ___ No
ii. Historical control ___ Yes ___ No
iii. Non-active control ___ Yes ___ No
iv. Patient as their own control ___ Yes ___ No
v. Objective Performance Criteria ___ Yes ___ No
vi. Other ___ Yes ___ No
If other, describe: ________________________________________________________
If alternatives could not be used, explain:______________________________________ ________________________________________________________________________
Was the use of surrogate endpoints considered?
___ Yes ___ No
Explain: ________________________________________________________________ _______________________________________________________________________
Was a least burdensome approach considered in determining how the primary and secondary endpoints will be measured?
___ Yes ___ No
Explain: ________________________________________________________________ _______________________________________________________________________
Was early submission of the application considered? That is, could the application be submitted after a mutually agreed to percentage of the patients had been followed for a pre-defined period of time?
___ Yes ___ No
Explain:_________________________________________________________________ ________________________________________________________________________
Was the role of postmarketing information considered as a mechanism of reducing the premarket requirements?
___ Yes ___ No
Explain:___________________________________________________________________
Were the least burdensome principles applied in other areas of the trial design not mentioned above?
___ Yes ___ No
If yes, describe: _____________________________________________________________ ___________________________________________________________________________ ___________________________________________________________________________ ___________________________________________________________________________ ___________________________________________________________________________ ___________________________________________________________________________
Applicant Contact Name and Phone Number (Optional):_______________________________
Once completed, fax to Ms. Wanda Sawyer-Major at (301) 594-297
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