Hello, I am Robert Lionberger, the director
of the Office of Research and Standards in the
Office of Generic Drugs.
This is a second video on the GDUFA II pre-ANDA
meeting system, so please watch the video on the
product development meetings before watching
this one.
The pre-ANDA program is new in GDUFA II and it's
designed to accelerate access to generic versions
of complex products.
Meetings between FDA and ANDA applicants are a
critical step toward meeting these goals.
GDUFA II describes three types of meetings for
prospective ANDA applicants seeking to
develop generic versions of complex products:
Product development meetings, Pre-submission
meetings, and Mid-review-cycle meetings.
Product development meetings were discussed in
detail in the Product Development Meetings
video.
This time, we will focus on pre-submission meetings
and mid-review-cycle meetings.
The pre-submission meeting provides a prospective
applicant the opportunity to discuss an ANDA to be
submitted within the next year.
At this meeting, FDA can give advice that will
support efficient review and improve the chance of
first cycle approval.
For example, FDA can identify items or
information that should be clarified before
submitting an ANDA.
FDA will also use this meeting to share
information from product development meetings with
the ANDA review team, and prepare for unique review
issues.
In GDUFA II negotiations, FDA and industry agreed
that FDA will generally grant pre-submission
meetings if an applicant has already had a product
development meeting.
FDA may grant a pre-submission meeting to
prospective applicants that did not have a
product development meeting if, in FDA's
judgment, the pre-submission meeting
would improve review efficiency and resources
are available.
To request any type of meeting, you need to take
several administrative steps.
First, request a pre-assigned ANDA number.
This will help us track your interactions with FDA
all the way to approval.
Second, with your pre-assigned ANDA number,
sign up to use the CDER Direct NextGen
Collaboration Portal, or simply The Portal, where
you can submit the meeting request.
A pre-submission meeting request should contain an
outline of the unique, novel or complex aspects
of your upcoming submission that you will
present at the meeting.
If you have specific questions, provide
appropriate background material and data related
to those questions.
FDA will evaluate the meeting request and
respond within the GDUFA II goal date.
For fiscal years 2018 and 2019, FDA will grant or
deny the meeting request within 30 days of receipt.
For fiscal years 2020 through 2022, FDA will
grant or deny the meeting request within 14 days of
receipt.
FDA will then conduct the pre-submission meeting
within 120 calendar days from the date the meeting
was granted.
You can check the status of your meeting requests
through the portal.
The Office of Regulatory Science project manager is
your point of contact for the meeting process.
During the review of your meeting package, FDA staff
will identify representatives of the
ANDA review team and other experts, as appropriate,
to participate in the pre-submission meeting.
FDA will communicate the results of the product
development meeting or other pre-ANDA
interactions to the review team before your meeting.
If you included questions with your meeting package,
you will receive preliminary written
comments 5 calendar days before the meeting.
At this time, you should also submit your final
meeting slides and agenda to the portal.
On the meeting day, FDA staff will listen to your
presentation about the unique, novel or complex
aspects of your upcoming submission.
FDA staff will then provide feedback on how to
present the information in your submission.
This will enable an efficient review and
increase the potential for a first cycle approval.
FDA staff will also discuss the written
responses to your questions.
FDA will not provide a substantive review of
summary data or full study reports during this
meeting.
After the meeting, FDA will issue official
minutes within 30 days.
If you'd like FDA to take your perspective into
consideration, you can submit your meeting
summary via the portal.
Remember, however, that FDA minutes are the
official record of the meeting.
After your pre-ANDA meetings and after using
the same pre-assigned ANDA number to submit your ANDA
through the portal, the regulatory project manager
will contact you to arrange a mid-review cycle
teleconference.
Pre-Submission meetings are a new part of GDUFA
II.
They are intended to accelerate access to
generic versions of complex products by making
the ANDA review more efficient.
We believe this tool will help reduce the number of
review cycles necessary to obtain ANDA approvals of
complex products.
Thank you.