21 cfr 314.50 a 5

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.
A description for this result is not available because of this site's hanna-barbera.info. 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.

21 cfr 314.50 a 5 - wikipedia band

Federal Rules of Bankruptcy Procedure. In the case of any discrepancy in meaning, the English version is considered official. Federal Rules of Evidence. Training and Continuing Education. Proximity Search History Search Tips Corrections Latest Updates User Info FAQs Agency List Incorporation By Reference. I, name of applicant , certify that Patent No. A section describing the statistical evaluation of clinical data, including the following:.

21 cfr 314.50 a 5 - free slots

These amendments reorganize, modify, and clarify current regulations concerning who must register establishments and list human drugs, human drugs that are also biological products, and animal drugs. GPO FDSys: XML Text. Electronic Code of Federal Regulations. The application is required to contain reports of all investigations of the drug product sponsored by the applicant, and all other information about the drug pertinent to an evaluation of the application that is received or otherwise obtained by the applicant from any source. Proximity Search History Search Tips Corrections Latest Updates User Info FAQs Agency List Incorporation By Reference. If the applicant and FDA agree, the applicant may submit tabulations of patient data and case report forms in a form other than hard copy, for example, on microfiche or computer tapes.