Hi, I'm Michael Folkendt, Associate Director for
Regulatory Affairs in the Office of Pharmaceutical
Quality.
This presentation will cover one of the generic
drug review enhancements added as part of the
Generic Drug User Fee Amendments of 2017, or
GDUFA II - The Discipline Review and Information
Request letters.
An important enhancement of GDUFA II is in the ANDA
review process.
A.N.D.A.
stands for abbreviated new drug application and it
refers to the application for a generic drug.
New in GDUFA II is the introduction of two
specific types of letters to improve communications
during a review-cycle.
They are Discipline Review Letters, or DRL, and
Information Request Letters, or IR letters.
It also should be noted that there will no longer
be communications labeled as ECD, or easily
correctable deficiencies.
The Discipline Review letter, or DRL, is used to
convey preliminary thoughts on possible
deficiencies found by a discipline reviewer,
and/or a review team at the conclusion of the
discipline review.
It is important to note that these are preliminary
findings by the primary reviewers and may or may
not represent management review at the time the DRL
is issued.
The DRLs are expected to be issued at about the
mid-point of the review cycle and each discipline
is responsible for issuing their respective DRL.
For the purposes of implementing this review
enhancement, the three disciplines are labeling,
bioequivalence and quality.
At "about the mid-point" of the review cycle is
defined as the mid-point of the GDUFA review clock
plus one month.
The conclusion of the discipline review has
occurred when, at a minimum, the primary
reviewer of a discipline has read their section of
the ANDA and developed preliminary thoughts on
possible deficiencies.
If the discipline completes the review of
additional information received in response to a
DRL, another DRL may be issued until it is no
longer feasible, within the current review cycle.
The information request, IR, letter is the second
type of communication the applicant may receive
during the review of an ANDA.
The GDUFA II Commitment Letter states that an IR
letter is used to request further information or
clarification that is needed or would be helpful
to allow completion of the discipline review.
As such, it may also include a requested
response time period in order to facilitate the
completion of the discipline's review.
If a response is not received in a timely
manner, the request may become a possible
deficiency in a subsequent DRL or Complete Response
letter.
Note that the first IR letter may be issued as
soon as the ANDA is "Received." What is the
impact?
For the CDER reviewers and project managers, the
review of original ANDAs must begin much earlier in
the review cycle in order to complete the
preliminary review prior to the mid-point of the
review.
For ANDA applicants, this review enhancement
provides improved predictability and
transparency of the ANDA review process.
Applicants can expect to receive feedback at about
the mid-point of the review clock, if not
earlier.
This allows the applicant and FDA an opportunity to
try to resolve issues in the same review cycle and
improves review efficiency by reducing the number of
review cycles.
This will also bring generic drug products to
the market faster which will benefit the American
public.
Industry plays a role in the success of GDFUA II.
It starts with preparing and submitting high
quality, complete applications.
Once the application is submitted and received,
promptly responding to IR and DRL can have a large
impact on the efficiency of the review process and
may lead to quicker approvals.
Requested response dates may be provided in the
letter to assist the applicant.
When you respond to the IRs and DRLs, it is
strongly recommended that you only submit the
requested information and not include or submit any
unsolicited information.
Applicants can also benefit from previous DRLs
and IRs to improve the quality of future ANDA
applications.
Everyone plays a role in the successful
implementation of this program - industry,
reviewers, and discipline project managers.
The review process and issuance of IRs and DRLs
are monitored by discipline project
managers using internal dashboards as part of the
CDER Informatics Platform.
You can find additional information on this topic
listed on this slide.
The CDER guidance document and a MAPP will be
published early in the implementation of GDUFA
II.
Your OGD Regulatory Project Manager is your
best source of information about review enhancements
and goals related to a specific application.
The Discipline Project Manager is the best source
of information about specific Information
Requests and Discipline Review Letters.
Thank you for your interest.