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Section 514.1
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Definitions |
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Section 514.3
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Substantial evidence |
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Section 514.4
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Presubmission conferences |
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Section 514.5
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Amended applications |
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Section 514.6
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Withdrawal of applications without prejudice |
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Section 514.7
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Supplements and other changes to an approved application |
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Section 514.8
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Confidentiality of data and information in a new animal drug application file |
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Section 514.11
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Confidentiality of data and information in an investigational new animal drug notice |
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Section 514.12
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Untrue statements in applications |
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Section 514.15
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Records and reports concerning experience with approved new animal drugs |
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Section 514.80
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Evaluation and comment on applications |
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Section 514.100
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Approval of applications |
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Section 514.105
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Approval of supplemental applications |
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Section 514.106
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Reasons for refusing to file applications |
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Section 514.110
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Refusal to approve an application |
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Section 514.111
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Withdrawal of approval of applications |
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Section 514.115
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Notice of withdrawal of approval of application |
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Section 514.116
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Adequate and well-controlled studies |
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Section 514.117
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Revocation of order refusing to approve an application or suspending or withdrawing approval of an application |
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Section 514.120
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Service of notices and orders |
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Section 514.121
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Contents of notice of opportunity for a hearing |
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Section 514.200
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Procedures for hearings |
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Section 514.201
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Judicial review |
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Section 514.235
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Medicated feed mill license applications |