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21 cfr 312.22 d

21 cfr 312.22 d

(d ) A description of the design of the study, including the kind of control group to be used, if any, and a description of methods to be used to minimize bias on the.
For name(s) of drug (21 CFR list the generic name(s) and authorizing FDA to refer to the information (21 CFR (d)), (21 CFR (b)).
21 CFR CGMP regulations for finished Regulatory Basis (cont' d.) • Preamble to 1978 CGMP . “Safety and rights of subject” 21 CFR (a). A copy of all labels and labeling to be provided to each investigator. Subpart E-Drugs 21 cfr 312.22 d to Treat Life-threatening and Severely-debilitating Illnesses. 21 cfr 312.22 d sponsor shall OR 101 submit a copy of each original literature publication for which an English translation is submitted. If requested by FDA, any other relevant information needed for review of the application. A section describing the pharmacological effects and mechanism s of action of the drug in animals, and information on the absorption, distribution, metabolism, and excretion of the drug, if known. A sponsor-investigator who uses an investigational drug not subject to a manufacturer's IND or marketing application is 1733 in Scotland required to submit all technical information supporting the IND, unless such information may be referenced from the scientific literature. Subpart B-Investigational New Drug Application IND.

21 cfr 312.22 d - state:

Subsequent amendments to the IND that contain new or revised protocols should build logically on previous submissions and should be supported by additional information, including the results of animal toxicology studies or other human studies as appropriate. As drug development proceeds, the sponsor is required to submit informational amendments, as appropriate, with additional information pertinent to safety. A sponsor-investigator who uses, as a research tool, an investigational new drug that is already subject to a manufacturer's IND or marketing application should follow the same general format, but ordinarily may, if authorized by the manufacturer, refer to the manufacturer's IND or marketing application in providing the technical information supporting the proposed clinical investigation. A cover sheet for the application containing the following: i The name, address, and telephone number of the sponsor, the date of the application, and the name of the investigational new drug. Subpart I--Expanded Access to Investigational Drugs for Treatment Use. Food and Drug Administration.