All Other Information (AOI)

All Other Information
(AOI)
Sharon Chase, DVM
Center for Veterinary Medicine
Office of New Animal Drugs Evaluation
HFV-114
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What is All Other Information?
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Information pertinent to an evaluation of the
safety and effectiveness from any source,
including information derived from other
investigations, foreign market experience,
scientific literature, both favorable and
unfavorable (21 CFR 514.1 (b)(8)(iv))
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What is All Other Information?
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The AOI is part of the evidence needed to
establish safety and effectiveness
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When is AOI reviewed?
“AOI of a major technical section”
z As part of the following major (“P”) technical
sections:
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Target animal safety
Effectiveness
Human food safety
The information submitted in the AOI at this
stage is information pertinent only to the
technical section under review
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When is AOI reviewed?
“AOI minor technical section”
z When the last major technical section (“P”) is
submitted
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The AOI is considered a minor (“M”) technical
section
The AOI is usually submitted concurrently with the
Labeling minor technical section
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What does AOI include?
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Generally, information involving the active
ingredient of the new animal drug in the
target, and sometimes non-target species.
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Any new information that may impact our
decision on safety and effectiveness
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What does AOI include?
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More specifically, the AOI includes, but is not limited
to:
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Any information derived from domestic and foreign
marketing
Pilot studies
Summary data from any extended use studies
Scientific literature, both favorable and unfavorable
z Full text articles are helpful, but adequate summaries may
be acceptable
Internal, unpublished documents
Summary of foreign Adverse Drug Events (e.g., PSURs)
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Timing of submission
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AOI is submitted:
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As part of the Target Animal Safety,
Effectiveness, and Human Food Safety technical
sections (major technical sections) during the
phased review process.
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After the last major technical section is submitted.
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The AOI minor technical section may be submitted
concurrently with the last major technical section (final
“P” submission)
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Timing of submission
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The AOI minor technical section:
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Should only include new information that was not
available to the sponsor at the time that the major
technical sections were submitted to CVM
Is assigned the same due date as the last open
major technical section (“P” submission)
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If an ERA is requested for the last open “P”
submission, the due date of the AOI submission is
adjusted accordingly. The sponsor should also amend
the pending AOI.
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Timing of submission
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If there is no new information since the last
major technical section was submitted to
CVM, the AOI minor technical section should
still be submitted with a statement to that
effect
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Timing of submission:
Administrative NADA
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The AOI minor technical section complete
letter is valid for 90 days from the date the
letter is issued from CVM
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Therefore, the administrative NADA should
be submitted within 90 days of the issuance
of the AOI minor technical section complete
letter
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Administrative NADA
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If the administrative NADA is submitted after
90 days, the AOI minor technical section will
need to be updated by the sponsor
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To allow time for CVM to review the updated
AOI submission, the administrative NADA will
be re-coded as a non-administrative NADA
(180 day review clock)
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Features of a “Good” AOI
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Accurate and complete translations of foreign
literature
Foreign labeling, if applicable
Any adverse events not previously reported
to CVM
If providing abstracts, ensure that the studies
have not previously been submitted
Summary information, not raw data
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Contact CVM
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We strongly recommend that you contact us
with any questions you might have
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If you have questions about the need to submit
AOI related to human use
If your product has many years of use… and
therefore a large amount of information available
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Thank You!
Sharon Chase, DVM
Veterinary Medical Officer
Office of New Animal Drug Evaluation
Center for Veterinary Medicine/FDA
[email protected]
Phone: 240-276-8326
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