Individuals & Families
Small Businesses
Nonprofits
Employers
Employee Benefits Brokers
PEOs
Credit Unions
Membership Groups
Legal Information
Sign In
/
U.S. Code of Federal Regula...
/
Title 21-Food and Drugs
/
CHAPTER I—FOOD AND DRUG ADM...
/
PART 514—NEW ANIMAL DRUG APPLICATIONS
PART 514—NEW ANIMAL DRUG APPLICATIONS
§ 514.1 - Applications.
§ 514.3 - Definitions.
§ 514.4 - Substantial evidence.
§ 514.5 - Presubmission conferences.
§ 514.6 - Amended applications.
§ 514.7 - Withdrawal of applications without prejudice.
§ 514.8 - Supplements and other changes to an approved application.
§ 514.11 - Confidentiality of data and information in a new animal drug application file.
§ 514.12 - Confidentiality of data and information in an investigational new animal drug notice.
§ 514.15 - Untrue statements in applications.
§ 514.80 - Records and reports concerning experience with approved new animal drugs.
§ 514.87 - Annual reports for antimicrobial animal drug sales and distribution.
§ 514.100 - Evaluation and comment on applications.
§ 514.105 - Approval of applications.
§ 514.106 - Approval of supplemental applications.
§ 514.110 - Reasons for refusing to file applications.
§ 514.111 - Refusal to approve an application.
§ 514.115 - Withdrawal of approval of applications.
§ 514.116 - Notice of withdrawal of approval of application.
§ 514.117 - Adequate and well-controlled studies.
§ 514.120 - Revocation of order refusing to approve an application or suspending or withdrawing approval of an application.
§ 514.121 - Service of notices and orders.
§ 514.200 - Notice of opportunity for hearing; notice of participation and requests for hearing; grant or denial of hearing.
§ 514.201 - Procedures for hearings.
§ 514.235 - Judicial review.