Hello, I am Robert Lionberger, the director
of the Office of Research and Standards in the
Office of Generic Drugs.
In this presentation, I'll walk you through the GDUFA
II pre-ANDA meeting system and focus on the product
development meeting available to prospective
applicants submitting abbreviated new drug
applications - or A.N.D.As - for complex generic drug
products.
The pre-ANDA program is new in GDUFA II and it is
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.
The product development meeting is a scientific
meeting on a specific issue for a complex
generic product.
FDA will provide advice and feedback to applicants
on new or alternative approaches to
demonstrating equivalence to the reference listed
drug.
In GDUFA II negotiations, FDA and industry agreed
that FDA will grant product development
meetings if certain conditions are met.
The meeting must concern a complex product that does
not have FDA guidance for the reference product, or
the applicant has an alternate approach to
demonstrating bioequivalence to the
complex reference product, such as in vitro
replacement of clinical endpoint bioequivalence
study.
The package must be complete, and the
questions should be beyond the scope of what a
controlled correspondence could answer, as a new
bioequivalence approach always is.
Most importantly, the meeting is designed to
improve ANDA review efficiency.
So we will not be answering your questions
about NDA submissions.
These conditions ensure the meetings prioritize
situations where there is no clear path for
generics.
If these conditions are not met, then FDA has the
option of granting a meeting or directing the
applicant to use other parts of the pre-ANDA
program such as controlled correspondence.
A complex product is defined in the GDUFA II
commitment letter and includes products with
complex active ingredients, formulations,
routes of delivery or dosage forms, complex
drug-device combinations, or other products where
complexity or uncertainty concerning the approval
pathway or other alternative approach would
benefit from early scientific engagement.
In order to request your product development
meeting, you need to take several administrative
steps: First, request and obtain 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,
you can sign up for and use the CDER Direct
NextGen Collaboration Portal, or simply The
Portal, to submit your meeting request.
Remember that you must submit a complete meeting
package.
A complete meeting package contains clear and
specific questions that are supported by
appropriate data.
The product development meeting is not a fishing
expedition.
It is for prospective ANDA applicants who are
actively engaged in product development.
FDA's experience shows that data in the meeting
package leads to more useful and practical
discussion during the meeting.
There are different FDA staff members who will be
involved in evaluating your meeting package: The
signatory authority will make the final decision on
granting your meeting.
He or she also will oversee the process and is
accountable for the outcomes of the meeting.
A project manager from the Office of Research and
Standards, or ORS project manager, will be your
point of contact and run the internal process.
And the meeting team lead will coordinate the
technical content from all disciplines into a
consistent response.
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 conduct the product development
meeting within 120 calendar days from the
date the meeting was granted.
You can check the status of your meeting requests
using the portal.
To evaluate your meeting package, FDA staff builds
on the scientific foundation that comes from
our GDUFA research program.
In preparation for the meeting, FDA may request
that you provide additional information.
You can use the portal to submit your responses to
these information requests.
FDA will provide preliminary written
comments 5 calendar days before the product
development meeting.
Use these comments to prioritize your time with
FDA.
Focus on the questions that need more
clarification.
At this time, you should also submit your final
meeting slides and agenda to the portal.
On the meeting day, you can expect interactive
discussion with FDA about the questions posed and
the data provided in your meeting package.
Our goal is to assist your development program and
move you towards submitting an ANDA.
However, FDA cannot review any material presented at
the meeting for the first time.
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.
However, be advised that FDA minutes are the
official record of the meeting.
Product development meetings are a new part of
GDUFA II.
They are intended to accelerate access to
generic versions of complex products.
We look forward to using these meetings to interact
with industry to support innovative and efficient
methods to demonstrate equivalence.
Thank you and be sure to watch on the video on
pre-submission meetings.