Title 21, Part 514 — New Animal Drug Applications
25 sections
Section 514.1
Applications.
Section 514.3
Definitions.
Section 514.4
Substantial evidence.
Section 514.5
Presubmission conferences.
Section 514.6
Amended applications.
Section 514.7
Withdrawal of applications without prejudice.
Section 514.8
Supplements and other changes to an approved application.
Section 514.11
Confidentiality of data and information in a new animal drug application file.
Section 514.12
Confidentiality of data and information in an investigational new animal drug notice.
Section 514.15
Untrue statements in applications.
Section 514.80
Records and reports concerning experience with approved new animal drugs.
Section 514.87
Annual reports for antimicrobial animal drug sales and distribution.
Section 514.100
Evaluation and comment on applications.
Section 514.105
Approval of applications.
Section 514.106
Approval of supplemental applications.
Section 514.110
Reasons for refusing to file applications.
Section 514.111
Refusal to approve an application.
Section 514.115
Withdrawal of approval of applications.
Section 514.116
Notice of withdrawal of approval of application.
Section 514.117
Adequate and well-controlled studies.
Section 514.120
Revocation of order refusing to approve an application or suspending or withdrawing approval of an application.
Section 514.121
Service of notices and orders.
Section 514.200
Notice of opportunity for hearing; notice of participation and requests for hearing; grant or denial of hearing.
Section 514.201
Procedures for hearings.
Section 514.235
Judicial review.