How is the regulatory review period for an animal drug determined?
For animal drugs where the New Animal Drug Application (NADA) components were submitted to FDA in a phased review, the approval phase begins on the date of the submission of the administrative NADA.
As stated in MPEP 2757: “To determine the regulatory review period for an animal drug where the New Animal Drug Application (NADA) components were submitted to FDA in a phased review, the approval phase, as defined by 35 U.S.C. 156(g)(4)(B)(ii), begins on the date of the submission of the administrative NADA.” This determination was established in the case of Wyeth Holdings Corp. v. Sebelius.
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Topics:
Adjustments,
And Extensions,
MPEP 2700 - Patent Terms,
MPEP 2757 - Regulatory Agency Determination Of The Length Of The Regulatory Review Period,
Patent Law,
Patent Procedure