Pre-IND meeting

In some instances, the FDA and drug sponsor (company/institution submitting the IND) will agree to hold a pre-IND meeting. This aims to acquaint the FDA officials with the background to/content of the IND application, and to get a feel for whether the IND application will be... 

Research (CDER) for small molecule synthetic drugs and therapeutic biologies, and the Center for Biologies Evaluation and Research (CBER) for non-therapeutic biologies (see Sections 7.2.1 and 7.2.2). A pre-IND meeting can be arranged with the FDA to discuss a number of issues ... 

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. 

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). 

Focus of Meeting. The pre-IND meeting should focus on the specific questions related to the planned clinical trials. The meeting should also include... 

Can pre-IND meetings reduce time to market Yes, time can be reduced by the following ... 

In the process of drug development, when can a pre-IND meeting be very important ... 

Can pre-IND meetings be helpful in developing a strategy for drug development Yes. The following can be helpful in developing a strategy. 

Are there recurrent problems at pre-IND meetings Yes, the following have been identified in pre-IND meetings. 

Make sure that a pre-IND meeting is necessary answers to your questions may be available in the guidances. 

The basic safety studies, including the International Conference on Harmonization (ICH) standard series of preclinical tests, receive close attention in the NDA review. Even if specific ICH studies were never discussed in the pre-IND meeting, the IND review, and the pre-NSDA meeting, they should be addressed in the NDA. 

This discussion understandably cannot address whether the results of the preclinical studies that were conducted would support the proposed clinical trials (e.g., the proposed first-in-human dose). For that reason, or for other reasons, a development project team might choose to request a pre-IND meeting or an earlier meeting. 

In preparing for a pre-IND meeting, the DRA representative should provide the FDA with summary documents of the subjects to be discussed. The question of confidentiality must be carefully considered. With no IND filing reference number, the information submitted should be general in nature. Complete details of the synthesis and chemical structure should not be provided. It is usually sufficient to vaguely describe the compound and identify it by code number. 

Many Europeans are surprised at the access that pharmaceutical companies have to the reviewing divisions of FDA. The typical investigational drug will be the subject of a pre-IND meeting, which FDA will provide at its discretion and for which the agenda may be set by the prospective... 

A further example relates to the pre-IND meeting. Some FDA divisions do not like them, and if reviewers attend, they have a tendency to provide less valuable information than they would for an EOP2 meeting or a pre-NDA meeting, the so-called entitled meetings . But, within the industry, there are a number of companies who have similar attitudes about the value of pre-IND meetings. The notable difference is that the FDA has to go to the pre-IND meeting if scheduled. The companies who see little value merely do not schedule them. 

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