Welcome to GDUFA II Goals training.
My name is Vince Sansone, and I'm the Acting Deputy
Director of the Office of Regulatory Operations in
the Office of Generic Drugs.
I'm going to take you through the performance
goal dates associated with the reauthorization of the
Generic Drug User Fee Amendments or GDUFA II --
as they are stated in the GDUFA II Commitment
Letter.
We'll go over how they will affect FDA reviewers'
daily work, industry's submissions, action dates,
and communications between the FDA and industry
during review cycles.
To begin, let's take a look at what is new or
changed from GDUFA I.
GDUFA II removes tier classification of
amendments.
All abbreviated new drug applications or ANDAs
received on or after October 1, 2017, will
receive a standard or priority designation.
And depending on the designation, the
appropriate goal dates will be assigned as
outlined in the GDUFA II Commitment Letter.
In GDUFA II, FDA is committed to meeting goal
dates for 90% of all ANDA originals, amendments, and
prior approval supplements submissions.
This slide depicts the 90% goal metric applied to
originals and amendments, and how the potential goal
dates are calculated based on certain criteria.
For example, priority vs.
standard and if a Pre-Submission Facility
Correspondence was submitted.
Let's consider a possible scenario.
A major amendment with priority status could
receive a goal date as short as 6 months if a
pre-approval inspection is not required.
This table follows the same logic as the previous
slide but with regards to Prior Approval Supplements
and their amendments.
The impact of these GDUFA II changes is twofold.
One - applicants have opportunities to receive
shorter goal dates under certain conditions and two
- there are more predictable dates or
timelines for ANDA actions and communications during
review cycles.
In GDUFA II, both the FDA and ANDA applicant have
distinct responsibilities and roles.
The applicant is responsible for submitting
ANDAs, amendments, and supplements with required
information, such as a complete and accurate Form
FDA 356h.
For applicants who desire consideration for priority
designation, the request should be formally
submitted, and the reason for requesting priority
designation should be clearly cited, as outlined
in MAPP 5240.3.
The FDA determines submission goal dates for
original ANDAs.
The Division of Filing Review determines the goal
date when an application is filed based on receipt
date, priority designation, and
submission of a substantially complete
application.
For ANDA amendments, the regulatory project manager
determines the goal date based on receipt date,
major vs.
minor, priority designation, and need for
inspection.
For Prior Approval Supplements, the
regulatory project manager from the Office of Generic
Drugs, regulatory business process manager from the
Office of Pharmaceutical Quality, or labeling
project manager from the Office of Generic Drugs
determines the goal date based on receipt date,
priority designation, and need for inspection.
For submissions that require inspection, the
goal date may be affected by whether the applicant
submitted a complete and accurate pre-submission
facility correspondence (or PFC) that remains
unchanged at the time of the ANDA submission.
How will Success be measured?
Success will be measured against the 90% metric
from the GDUFA II Commitment Letter for each
of the categories listed on this slide: ANDA
originals; ANDA amendments; Prior Approval
Supplements, and Prior Approval Supplement
amendments.
FDA will make every effort to either meet or exceed
the 90% metric outlined in the GDUFA II Commitment
Letter.
What can Industry do to assist?
Generic Drug Applicants can promote success by
submitting clear and complete applications.
For example, ensure that each submission contains a
complete and accurate Form FDA356h.
Requests for priority designation should be
noted on the submission cover letter and contain
the information requested in MAPP 5240.3,
Prioritization of the Review of Original ANDAs,
Amendments, and Supplements.
Also, cover letters, as applicable, should
reference any Pre-Submission Facility
Correspondence, or PFC, the date the PFC was
submitted, and the date of FDA's acknowledgement
letter indicating the PFC's eligibility for
further assessment.
We recommend submitting a stand-alone
certification statement in your submission confirming
that the facility information initially
submitted in the PFC has not changed with the ANDA
submission.
We recommend that any and all differences
between the facility information submitted in
the ANDA versus the PFC, be identified in the
recommended stand-alone certification statement.
This assists the Division of Filing Review project
managers and the regulatory project
managers in triaging the submission more
efficiently and accurately.
The goal date tables provided earlier in the
presentation are straight from the GDUFA II
Commitment Letter.
The commitment letter is the primary resource for
operationalizing GDUFA II goal date setting.
Here are additional resources that applicants
and FDA personnel can reference for additional
questions: the GDUFA II Commitment Letter, which
defines how goal dates are established; the
Amendments Guidance, which provides applicants with
the proper procedures of ANDA amendment submission,
and the Prioritization MAPP, which outlines the
criteria for what defines a priority submission.
Please remember that the primary point of contact
post-Filing is the Regulatory Project Manager
regarding Original A.N.D.A.
submissions and their amendments.
For Prior Approval Supplements, the primary
contact will be dependent upon on the disciplines
involved.
Labeling PASs will be the Labeling PM; Quality PASs
will be the RBPM; and PASs with two or more
disciplines will be the RPM.
Thank you for your time.