Meeting requests

Responds as the expert resource for CDER to issues and meeting requests from the Office of the Commissioner and interfaces on common botanical issues and fosters communication with the FDA Center for Food Safety and Applied Nutrition and the National Center for Complementary and Alternative Medicine and the Office of Dietary Supplements at the National Institutes of Health (NIH). 

One source of that advice is the FDA itself. There are formal FDA meetings, which require a written meeting request and briefing book (see Chapters 2 and 3), most appropriate before development and submission of an IND or an NDA. Less formally, FDA spokespersons often make presentations at local and national conferences. Their presentations are often available on the FDA Web site (http // www.fda.gov) as well as through the specific conference. Finally, some individuals from the FDA will respond directly to telephone or e-mail questions. All three of these sources can be effective information conduits and can help build strong contracts and relationships within the FDA. 

Keep the FDA informed. Once a file has been opened through a meeting request, inquiry, or submission, the project is assigned to an FDA contact. That designated individual can serve as a conduit to appropriate directors, committees, review boards, and divisions. 

The submissions process can be traumatic. Whether you are a start-up company filing your first meeting request or a major pharmaceutical organization with an NDA for the latest blockbuster, there is a great deal resting on the process and the result. 

For meeting requests, orphan-drug applications, INDs, NDAs, 505b(2) NDAs, Abbreviated New Drug Applications (ANDAs), Orphan Annual Reports, and Annual Reports, the tools, checklists, and FDA guidelines are provided. With this tool kit, your organization can regain control of a rational, predictable submissions process. 

Whether the meeting requested is to discuss an initial program of clinical research (the pre-IND meeting), to outline the intended IND or Abbreviated New Drug Application (ANDA), or to obtain feedback on an interim step or issue, the key to an effective meeting request letter lies in the questions posed. These questions are not the result of casual listing but rather are carefully crafted to obtain the results you are seeking. 

The Meeting Request, Briefing Book, actual meeting, and FDA Summary Memo will provide important context and reaction to the planned IND, NDA,... 

Perhaps uniquely, the FDA has developed and distributed its own checklist for meeting requests, used internally to evaluate requests when they are received. Presumably, this unusual inclusion is a result of the relatively mundane—administrative only—review. The checklist can be found in the second FDA document included here How to Submit a Request for a Meeting or Teleconference in Electronic Format to CVM — Checklist. ... 

This checklist is intended for use in the preparation and submission of Meeting Requests. It is recommended that, prior to transmission to the FDA, a second internal review be conducted by an individual or department not involved (presumably Quality Assurance) in the preparation of the submission. 

Meeting request begins with a brief—approximately one-page—summary of developmental plan (i.e., in a request for a pre-IND meeting, summary describes planned IND process a pre-NDA meeting describes the intended NDA procedures). 

Meeting Request. For general information on procedures for written meeting requests, sponsors should refer to the regulations, guidances, and policies and procedures listed in the Introduction. The request should contain a list of the specific objectives and/or desired outcomes of the meeting, including a draft list of CMC-related questions. 

Meeting Request, Information Package, and Format See General Aspects regarding the meeting request, information package, and format of the meeting. 

Electronic records may be submitted instead of paper records, provided the requirements of Part 11 are met (21 CFR 11.2). The procedures in this guidance are designed to provide for a means of electronic submission that meets the requirements of Part 11. If an applicant does not follow this guidance to submit a meeting request electronically, the applicant should consult with the CVM regarding alternative methods for electronic submission that meet the requirements of Part 11 or submit the request in paper. 

Select the Insert Comments button to add a PDF file containing any comments regarding the meeting request. 

Copy of the meeting request with updates to reflect the most current information... 

The process of filing an IND follows a carefully prescribed route, though it may be possible to bypass some of the steps in the case of a clear and non-controversial drug. Generally, there are five steps meeting request, briefing book, meeting, submission, and remediation. 

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