1. II. Overall Format and Content of the Clinical and Statistical Sections 10. [ 21 CFR (d)(5) and A. List of Investigators and List of IND's and NDA's. 10.
(ii) The information required under (if an anti-infective drug), (d)(5), and (f) as needed to support the safety and effectiveness of the.
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The application may provide additionally for the use of alternatives to meet any of these requirements, including alternative sources, process controls, and analytical procedures. FDsys: GPO's Federal Digital System. Barring unforeseen circumstances, tabulations agreed to be deleted at such a conference will not be requested during the conduct of FDA's review of the application. A section describing the statistical evaluation of clinical data, including the following:. Skip to Common Links. The tabulations are required to include the data on each patient in each study, except that the applicant may delete play free online casino slots machines tabulations which the agency agrees, in advance, are not pertinent to a review of the drug's safety or effectiveness. FDA will maintain the archival copy during the review of the application to permit individual reviewers to refer to information that is not contained in their particular technical sections of the application, 21 cfr 314.50 a 5 give other agency personnel access to the application for official business, and to maintain in one place a complete copy of the application.