Issue Date: October 28, 2002
Issued by: Center for Veterinary Medicine
Topic(s): New Animal Drug Application (NADA)
Status: Final
CVM GFI #82 Development of Supplemental Applications for Approved New Animal Drugs
On November 21, 1997, President Clinton signed into law the Food and Drug Administration (FDA) Modernization Act of 1997 (FDAMA) (Pub. L. 105-115). Section 403 of FDAMA concerns the approval of supplemental applications for approved products. Among other things, section 403 requires FDA to issue guidance for sponsors of supplemental new animal drug applications (NADAs) that specifies data requirements that will avoid duplication of previously submitted data by recognizing the availability of data previously submitted in support of an original application (Section 403 (b)(2)).
Download the Guidance Document
