FDA Meeting Requests

In the 1980s and 1990s, the FDA generally refused all requests for meetings with individual companies. In the words of one FDA official, We are not your consultants.  

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. 

avoid asking questions to which you do not know the answer. This is not an opportunity for research or general education. Make certain you thoroughly understand the requirements and guidance relevant to your product, and craft questions that do not merely seek factual summary. 

Guidebook for Drug Regulatory Submissions, by Sandy Weinberg Copyright 2009 John Wiley Sons, Inc. 

Avoid questions in which you try to tie the Agency to a position based upon a precedent. The FDA is not required to consistently follow a historical position as conditions evolve, and prior actions of one part of the FDA do not create inviolate precedents incumbent on other parts. While there is an attempt by the Agency to maintain fairness and consistency, the fundamental issue always is human health and safety. Concerns emerging from differing conditions or from advances in the field will always trump consistency. 

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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. 

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. 

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. 

A copy of Form FDA 3489 Request for a Meeting or Teleconference (for use with electronic submissions) is available on the CVM Electronic Submission Page at http //www.fda.gov/cvm/esubstoc.html. 

Reserve sample size should be at least twice the quantity necessary to perform all tests to determine whether the test or control article meets its established specifications for identity, strength, quality, purity, and stability. By retaining twice the quantity necessary to perform all tests, the laboratory will be able to supply a sample to the FDA, if requested, and still retain sufiicient material to conduct its own tests. 

If the product is to be marketed in the United States, the plant must meet the FDA s good manufacturing practices (GMP) requirements (which now apply in most of the developed countries). If other products are being manufactured in a given plant for sale in the United States, it is not a certainty that the FDA will inspect the plant for the production of each new compound fhaf is to be produced therein. It is virtually certain that the plant will be inspected, however, if the company has not been previously cleared by the FDA for manufacturing or sale in the United States. Inspection is also likely if the new process represents a significant deviation from the processes that have been carried out in the plant in the past. Requests to the FDA for plant inspection should be made as early in the NDA cycle as the law permits as scheduling the actual date for inspection can be a problem. 

Phase I, II, and III Trials An IND is submitted for each phase of clinical trial. Phases I to III. At any stage of the trial, the FDA has the authority to put clinical hold on the trial until deficiencies or safety issues are resolved. The Sponsor can request meetings with the FDA at various stages ... 

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