21 CFR 514.4 - Substantial evidence
| Cite as | 21 CFR 514.4 |
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18 practice notes
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Agency information collection activities; proposals, submissions, and approvals,
...evidence'' of effectiveness. Following notice and comment rulemaking, FDA further defined substantial evidence at Sec. 514.4 (21 CFR 514.4) (OMB control number 0910-0356). Because Sec. 514.4 is only a definition, it should not be viewed as creating an additional collection burden; the colle......
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Agency Information Collection Activities; Proposed Collection; Comment Request; Antiparasitic Drug and Resistance Survey
...automated collection techniques, when appropriate, and other forms of information technology. Antiparasitic Drug and Resistance Survey--21 CFR Part 514.4 (OMB Control Number Resistance of parasites to one or more of the major classes of FDA approved antiparasitic drugs is a documented probl......
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Food and Drug Administration's Evaluation of Approaches To Demonstrate Effectiveness of Heartworm Preventatives for Dogs; Request for Comments
...``an application may be refused unless it includes substantial evidence of the effectiveness of the new animal drug as defined in 514.4 21 CFR 514.4'' (21 CFR 514.1(b)(8)(ii)). Regarding studies, under 21 CFR 514.4(b)(3)(i) substantial evidence of the effectiveness of a new animal drug for ......
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Agency information collection activities; proposals, submissions, and approvals,
...techniques, when appropriate, and other forms of information technology. Substantial Evidence of Effectiveness of New Animal Drug--21 CFR 514.4(a) (OMB Control Number Section 512(d)(1)(E) of the Federal Food Drug and Cosmetic Act (the act) (21 U.S.C. 360b(d)(1)(E)) requires FDA to issue an ......
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