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C. PRE-EUA ACTIVITIES AND SUBMISSIONS
Early engagement between an industry or government sponsor and FDA about potential EUA products will facilitate more complete EUA requests and enhance FDA’s ability to review and ultimately grant the EUA as appropriate.

FDA also recognizes that circumstances can change rapidly, and planning for a potential emergency may unexpectedly transition to a response effort.

Therefore, FDA strongly encourages the sponsor of a product that might be considered for an EUA, particularly one at an advanced stage of development, to contact the appropriate FDA Center before submitting a formal request for an EUA. For purposes of this guidance, these submissions and related interactions are referred to as “pre-EUA” activities.

FDA’s review of a pre-EUA submission is not an indication of FDA’s views on the product’s potential to be used under an EUA, or that the sponsor has obtained or submitted all the information necessary for FDA to review a formal request for consideration of an EUA. Pre-EUA activities are not a substitute for sponsor efforts to develop the product toward approval, including submission and, when appropriate, implementation of proposals for clinical trials designed to determine whether the product is safe and effective for its intended use. In addition to design and implementation of clinical trials for development efforts in non-emergency settings, for some MCMs and for some emergency response plans, FDA encourages sponsors to design and propose appropriately controlled clinical trials that could be conducted during the emergency response either to run in parallel with an EUA or instead of an EUA.

Pre-EUA activities may include discussions with FDA about a potential EUA product. Such discussions may occur prior to the submission of a formal request for consideration of an EUA or issuance by the HHS Secretary of an EUA declaration. They may also include discussions about the appropriate vehicle to use (e.g., IND or IDE, Master File, pre-EUA submission) for submitting data on the product prior to submission of a formal request for consideration of an EUA.

Generally, FDA recommends that a sponsor submitting data as part of "pre-EUA” activities follow recommendations for submitting pre-IND, IND, and device pre-submissions to the relevant medical product Center.24 A "pre-EUA" submission is typically separate from other developmental submissions on file with FDA; its existence does not imply that any specific set of qualifications has been met but represents the initiation of a series of preliminary interactions to discuss potential suitability for EUA consideration. In addition, FDA requests that the sponsor follow the recommendations for the content of the submission outlined in section III.D.2 of this guidance and for the format of the submission contained in section III.D.3 of this guidance.

As with requests for issuance of EUAs, FDA prioritizes its pre-EUA activities based on a variety of factors. Many of these are discussed more fully in section III.D.4.a of this guidance. Examples of additional factors FDA may take into account in prioritizing pre-EUA activities may include: progress on product development targets or milestones; competing FDA obligations or exigent circumstances (e.g., user fee deadlines, other agency priorities); and whether there is a significant likelihood that the product would be retained in or added to government stockpiles if the product is authorized for use in an emergency. The extent of, and timelines for, review of such submissions will be determined on a case-by-case basis and will depend on the nature of the submission (e.g., whether an IND or IDE for the product already is on file), the circumstances of the emergency, and the workload of the review staff.

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