Department Of Health And Human Services
New Animal Drug Applications
October 23, 2009 - 74 FR 54749 - RIN: - Download Full Notice: Text | PDF
The Food and Drug Administration (FDA) is amending the regulations regarding new animal drug applications (NADAs). Specifically, this direct final rule is being issued to provide that NADAs shall be submitted in the described form, as appropriate for the particular submission. Currently, the regulation requires that all NADAs contain the same informational sections and does not explicitly
Agency Contact: Urvi Desai, Center for Veterinary Medicine (HFV-100), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-276-8297, e-mail: urvi.desai@fda.hhs.gov.
This rule is final. Its effective date is March 8, 2010.
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