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  1. Resources for You

Resources and First Steps for Aquaculture New Animal Drug Sponsors

This page will guide the aquaculture pioneer new animal drug sponsor through the first steps of opening an Investigational New Animal Drug (INAD) file and the New Animal Drug Approval (NADA) process. The steps to aquaculture drug approval are the same as those for any animal drug approval. That information is repeated here for your convenience. Additionally, there is specific information regarding environmental considerations and requesting authorization for investigational animals to enter the human food supply. Information about incentives applicable to aquaculture drug approval is also included.

For assistance in navigating the approval process, please email CVM.ONADE.PM@fda.hhs.gov.

NOTE: For sponsors seeking approval for an aquaculture drug that will be a copy of a previously approved drug, this is a generic new animal drug. Please contact the Division of Generic Animal Drugs at CVMDGADMGT@fda.hhs.gov. You may also refer to Abbreviated New Animal Drug Applications for more information on the generic new animal drug approval process.  

As a first step, we strongly encourage aquaculture new animal drug sponsors to review CVM GFI #61: Special Considerations, Incentives, and Programs to Support the Approval of New Animal Drugs for Minor Uses and for Minor Species.

There are alternatives to full NADAs, including Conditional New Animal Drug Approval (CNADA) and Indexing. More information on each of these is presented below.

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