CVM Announces Availability of Revised 356v Form

October 6, 2008

The following was updated on November 14, 2008, to include a link to the Q&As.

The FDA’s Center for Veterinary Medicine (CVM) is announcing revisions to the form used for submitting information for a New Animal Drug Application (NADA).

The newly revised form, FDA 356v, now allows for submission of conditional approvals and better accommodates the submissions relating to original NADAs, Supplemental NADAs, and Abbreviated New Animal Drug Applications (ANADAs).

The revised form has an expiration date of April 30, 2011. Applicants should discard previous versions of Form FDA 356v and use the newly revised version. For applications with cover letters dated before October 1, 2008, the previous version of the Form FDA 356v is acceptable.

A copy of the revised 356v form can be found on both the FDA Forms page and the CVM Forms page, or a copy can be requested by writing to

CVM Communication Staff, HFV-12
7519 Standish Place
Rockville, MD 20855

or by calling 240-276-9300.

For additional information, please see Q&As on the Revised 356v Form.