Description
CVM’s Office of New Animal Drug Evaluation (ONADE) encourages sponsors to submit data, study protocols, or other information for review at the most appropriate and productive times in the drug development process rather than submitting all data at one time in a New Animal Drug Application (NADA). Thus, sponsors may submit data intended to support an application for new animal drug approval during the investigation of the new animal drug to an investigational new animal drug (INAD) file.
Scope & Applicability
Product Classes
1The category of products covered by this guidance.
Stakeholders
2FDA personnel who view the application
Entity responsible for submitting applications under section 524B
Regulatory Context
Attributes
1Criteria for notifying a sponsor that a submission will not be accepted for review
Related CFR Sections (1)
- 21CFR514.110§ 514.110 Reasons for refusing to file applications.
(a) The date of receipt of an application for a new animal drug shall be the date on which the application shall be deemed to be filed.Read full regulation →
See Also (3)
- CVM GFI #132 Administrative Applications and the Phased Review Process (Status: Final)
- Harmonizing Compendial Standards With Drug Application Approval Using the USP Pending Monograph Process Guidance for Industry (Status: Draft)
- CVM GFI #227 Chemistry, Manufacturing, and Controls (CMC) Technical Section Filing Strategies (Status: Draft)