Application Summaries

Technology and Application—Summary, Zimpro Environmental Systems, Inc., Rothschild, Wise., 1978. 

USAEC Division of Civilian Application Summary Report AEC Reference Fuel-Processing Plant,... 

NDAs A single copy is required for each section. Two copies are required for Section 4 (Chemistry, Manufacturing, and Controls) and Section 6 (Fluman Pharmacokinetics and Bioavailability). A review copy of the application summary is required for each reviewer. 

A simple approach to specifying a suitable size enlargement method for a given application is by analogy to techniques currently used for similar materials. If a similar material can be identified in the applications summary of Table 1.4 (or in the more detailed information given in later chapters), and if process objectives are similar in terms of agglomerate size, strength, etc., then the methods used for the established product may well be applicable to the new material. 

Summary. This item, covered in the Guideline for the Format and Content of an Application Summary, will be reviewed later in this chapter. 

Each of the technical sections in the review copy must be separately bound in its own particular color folder as previously discussed. Each technical section should include an index (table of contents) for the section, a copy of the application form (FDA 356h), a copy of the cover letter, any letters of authorization, and a copy of the application summary. These items should be separated by tabs clearly marked as to the information being submitted. 

The U.S. Application Summary, EU Expert Report, stability reports, and drug product specifications will frequently define the time-critical path for NDA filing. These documents may be prototyped based on data from clinical batches and available data from registration batches. They cannot be finalized until the last stability data points are reported. 

Items A and B in the above outline have been previously discussed as to their content and listings. Items C through F are the essential parts of the NDA that will be reviewed, questioned, and scrutinized by the FDA and its advisors, as this information and data will be the deciding factor for an approved or not approved NDA. Therefore the content of the Application Summary must be done with precision and clarity and contain only scientific data that can be substantiated. 

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