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U.S. Department of Health and Human Services

For Industry

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What information and types of notifications are provided to sponsors during the new animal drug application review process?

Each new animal drug sponsor is assigned to a specific project manager.  When an investigational new animal drug file is opened by a sponsor, the assigned project manager will contact the sponsor to introduce themselves and provide their contact information.  In addition, the program manager will discuss the administrative processes with the sponsor and explain their role in those processes.

CVM’s Office of New Animal Drug Evaluation (ONADE) provides constant feedback to sponsors during the review process.  The process usually begins with a pre-submission conference (21 CFR 514.5), during which agreements regarding studies needed to support approval may be made.  Most sponsors participate in our phased review process.  After the review of each technical section submission, the sponsor will receive either a technical section complete letter or an incomplete letter, which describes the deficiencies noted in the submission.  Once all technical sections are complete, the sponsor submits an administrative new animal drug application, for which ONADE has 60-days to review.
 
Our policies and procedures (P&Ps) regarding the review of submissions related to new animal drug applications are available on the internet (http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/PoliciesProceduresManual/ucm046623.htm). 

We provide new staff training every year to train new reviewers and ensure that they are well-versed in our review process.  We also update and revise our P&Ps, as necessary, to ensure that they accurately reflect our current policies and processes.  When a P&P is revised, we alert our reviewers by email to ensure that they are aware of the change.

Relevant Resources:

  • P&P 1243.3050 Identifying and Documenting Technical Section Requirements for Approval   Effective Date: June 9, 2011 
  • P&P 1243.3051 Verifying Scope and Technical Section Status for Phased Review ([J]INAD) Projects in the End Game  Effective Date: June 9, 2011