Office of New Animal Drug Evaluation

The final difference is that the FDA analyst alone makes the recommendation based on the data for the acceptance of the confirmatory procedure. The conclusion of the analyst stating the suitability of the procedure for confirming the presence of the marker residue is sent directly to the CVM method trial coordinator in the Office of New Animal Drug Evaluation (ONADE) and not back to the sponsor as with the determinative procedure. 

Office of New Animal Drug Evaluation, Center for Veterinary Medicine,... 

Raafat Fahmy Office of New Animal Drug Evaluation, Center for Veterinary Medicine, Food and Drug Administration, Rockville, Maryland, U.S.A. 

This guidance represents the Agency s current thinking on how to submit a request for a meeting or teleconference in electronic format to the Office of New Animal Drug Evaluation (ONADE). It does not create or confer any rights for or on any person and does not operate to bind the FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statue and regulations. If you want to discuss an alternative... 

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