Pre-NDA meeting

If the clinical trials conducted under an IND are successful in demonstrating safety and effectiveness [often established at a Pre-NDA meeting, described in 21 CFR 312.47(b)(2)], the sponsor can then submit an NDA. Unlike an IND, the NDA must be specifically approved by the Agency. The toxicologist s responsibility in the... 

As preparations for the submission of an NDA begin, there needs to be a pre-NDA meeting with the EDA reviewing division. This meeting focuses on format, not content, and is important to eliminate delays that can occur when an NDA does not meet the specific needs of the assigned reviewers at the EDA (21 CER 312.47). The sponsor should provide to the FDA an idea of the t)q)es and volume of information to be submitted, as well as the plan for data summary, presentation and analysis. The FDA should provide to the sponsor any specific requests for the display and analysis of data. Electronic formats and requests have become more routine, and a good understanding of what is plaimed and needed can help improve efficiency and minimise later difficulties. 

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). 

The general aspects of pre-IND, EOP2, and pre-NDA meetings provided in this guidance summarize the information discussed in the formal meetings and fast-track drug development guidances listed in the Introduction, and supplement this information with respect to CMC. 

Typically, sponsors meet with the FDA to discuss the content and format of an NDA prior to its preparation. Such a pre-NDA meeting can be crucial for the sponsor to understand the content and format that will best facilitate the review process for a given submission. 

The case-by-case approach that is needed for the effective preclinical development of biopharmaceuticals requires close collaboration and agreement between the sponsor and the regulatory agency at all stages of development. In the United States, such collaboration and scientific advice is often achieved through interaction with the FDA at pre-IND, end of phase 2, or pre-NDA meetings with the Agency. 

The BRT will review clinical data in relation to the scope of the proposed clinical studies (1) preliminary studies (Phases I and II marketed product versus not-marketed products or products marketed with safety concerns), (2) expanded studies (Phase III), end-of-phase II meeting. The BRT will provide feedback and guidance at the pre-NDA meeting, then review the data in the NDA in relationship to safety, efficacy, quality, and therapeutic consistency. 

Before an NDA is submitted to the FDA, the applicant usually meets with the reviewing division in a pre-NDA meeting. The applicant presents a summary of the clinical studies, the proposed format for the organization of the NDA, and any other information the applicant considers relevant. The purpose of the meet-... 

Generally, the FDA also requires complete sets of CRFs for studies the sponsor has designated as adequate and well controlled. It is suggested that this be discussed at the pre-NDA meeting and CRFs for those studies be included in the NDA if requested by the FDA. 

The purpose of a pre-NDA meeting is to discuss the presentation of data (both paper and electronic) in support of the application. The information provided at the meeting by the sponsor includes ... 

A pre-NDA meeting is typically held as the phase III clinical trials are concluding. The principal objective is to check how the issues identified at the EOP2 meeting have been resolved. At this meeting, the entire structure of the forthcoming... 

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. 

Draft documents for the NDA are needed during phase 3 both for the pre-NDA meeting and for compilation and team review of a draft of the CMC section. 

Documents required for the pre-NDA meeting include the following items ... 

A pre-new drug application (pre-NDA) meeting may be requested by the sponsor to address outstanding questions and scientifrc issues and aid in the resolution of problems. The CMC portion of the pre-NDA meeting is a critical interaction between the CMC review team and the sponsor to ensure the submission of a well-organized and complete NDA. Examples of CMC issues that could be addressed in pre-NDA meetings include, but are not limited to... 

Pre-NDA meetings are held primarily to discuss the presentation and format of data supporting the application. Prior to the meeting, the sponsor should provide a summary of clinical studies submitted in the NDA, the proposed format for organization of the submission, and any outstanding questions. Although the primary purpose is to familiarize FDA staff with presentation and organization of the data to facilitate review, it also provides a final opportunity to discuss any unresolved problems or issues. 

---