Review teams, FDA

If the FDA files the NDA, an FDA review team is assigned to evaluate the sponsor s research on the drug s safety and effectiveness. 

Effective communication, both within the applicant s organization and with the FDA review team, is an integral part of planning any submission. It has been demonstrated consistently that the success of a new product application is dependent on the effectiveness of the organization s submission team and the working relationship developed between this group and the agency review team. 

The communication plan included direct interaction with the FDA review team to work through the issues early in the preparation of the NDA. 

The applicant team worked closely with the FDA review team to provide the requested analysis and data as quickly as possible. 

The appointment of an effective, empowered submission team that matched the key disciplines represented on the FDA review team kept the team intact and available for the entire review process. 

Establish meaningful dialogue with the FDA review team early in the process during the presubmission phase. 

The CDER Botanical Review Team website http //www.fda.gov/cder/Offices/ ODE V BRT/default.htm provides links to many useful EDA Guidances and related documents, including the Botanical Guidance and MAPP. 

Once the acceptability of the application is established, the primary review begins. Reviewers communicate with other reviewers and with the applicant regarding issues or questions that arise during the review. During the review process, the FDA reviewer may contact the application sponsor to discuss issues and obtain clarifications. Interactions between the review team and the applicant team can range from telephone calls to letters. If the reviewer requests assistance in finding information, it is important to respond quickly. A submission response team that is familiar with the information in the submission and its organization should be available to address questions as they are received. 

The FDA Review Checklists can be used by your internal QA team to self-regulate. Acting as FDA reviewers, they can confirm that your submission conforms to all format, content, and support requirements. And, of course, should the QA team find a weakness, you can correct and rereview prior to actual submission. 

Finally, the integrated team approach mimics and hence best meets the FDA review process. While a variety of FDA groups have input into an IND review, those subunits meet in a committee format to discuss and evaluate the submission. As a result, a number of their questions and concerns represent... 

Upon completion of preclinical, clinical, and dmg product development, the dmg company submits to the FDA for approval an NDA containing a meticulous, well-indexed, comprehensive, and readable document. The document should satisfy the requirements of the Food, Dmg, and Cosmetic Act and the code of Federal Regulations (CFR) used by the FDA in the review and approval of safe and effective dmg products in the United States. The FDA s NDA review process may last approximately two years. Multiple review teams are involved in the review process including ... 

A key member of the review team is the project manager, formerly called the consumer safety officer or CSO. The project manager evaluates regulatory information to determine compliance with current policies and regulations. In addition, project managers orchestrate and coordinate the drug review team(s) interactions, efforts, and reviews and they serve as the CDER review team s primary contact with the drug industry. They may be considered as the liaison between the FDA and industry. 

NDAs are forwarded to one of CDER s 14 new drug review divisions—specifically, the division that handles the therapeutic area relevant to the submission. Within 45 days of the NDA s submission, FDA reviewers—including the lead medical, chemistry, and pharmacology reviewers— will meet to determine if the application is sufficiently complete for a full review. NDAs that meet minimum submission criteria are filed, or accepted for review, while the FDA issues refuse-to-file (RTF) decisions for deficient applications, which are returned to their sponsors. Once the review team decides that an NDA is fileable, it begins the primary review of the application. During this evaluation, each member of the review team sifts through volumes of research data and information applicable to his or her expertise ... 

FDA established its QT interdisciplinary review team (IRT), which reviews protocols and study reports for thorough QT/QTc studies and advises review divisions accordingly... 

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