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Title 21 - Title 21

Part 514 - NEW ANIMAL DRUG APPLICATIONS

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Details about Part 514

Description

ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS - NEW ANIMAL DRUG APPLICATIONS

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25 sections

§514.1 - Applications.

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§514.100 - Evaluation and comment on applications.

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§514.105 - Approval of applications.

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§514.106 - Approval of supplemental applications.

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§514.11 - Confidentiality of data and information in a new animal drug application file.

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§514.110 - Reasons for refusing to file applications.

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§514.111 - Refusal to approve an application.

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§514.115 - Withdrawal of approval of applications.

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§514.116 - Notice of withdrawal of approval of application.

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§514.117 - Adequate and well-controlled studies.

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§514.12 - Confidentiality of data and information in an investigational new animal drug notice.

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§514.120 - Revocation of order refusing to approve an application or suspending or withdrawing approval of an application.

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§514.121 - Service of notices and orders.

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§514.15 - Untrue statements in applications.

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§514.200 - Notice of opportunity for hearing; notice of participation and requests for hearing; grant or denial of hearing.

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§514.201 - Procedures for hearings.

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§514.235 - Judicial review.

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§514.3 - Definitions.

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§514.4 - Substantial evidence.

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§514.5 - Presubmission conferences.

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§514.6 - Amended applications.

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§514.7 - Withdrawal of applications without prejudice.

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§514.8 - Supplements and other changes to an approved application.

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§514.80 - Records and reports concerning experience with approved new animal drugs.

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§514.87 - Annual reports for antimicrobial animal drug sales and distribution.

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