Investigative New Animal Drug
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The FDA INAD has a fee schedule for registering the use of investigative new animal drugs. http://www.fda.gov/cvm/aboutona.htm Any investigator who plans to utilize an investigative new animal drug as part of their research should coordinate their communications with FDA through the Research Compliance Office 335-1585. This communication is necessary to ensure that the appropriate waivers and exemptions with FDA Guidelines for Industry 170 "Animal Drug User Fees and Fee Waivers and Reductions" are applied. Also, any faculty member applying for an INAD or causing the FDA to open an existing INAD file (such as for a revision, etc…) significant fees may be incurred. |