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Martha Nguyen, JD

Office of Generic Drugs, CDER


Overview:
Draft Guidance for Industry
ANDA Submissions Prior
Approval Supplements Under
GDUFA

Background GDUFA Goals
GDUFA is designed to bring greater predictability and timeliness to the
review of generic drug applications by enabling FDA to assess user fees to
fund critical and measurable improvements to FDAs generic drug
program.

In the Commitment Letter that accompanied the legislation, FDA has
committed to review and act on a certain percentage of prior approval
supplements (PAS) within a specified time period from the date of
submission for receipts starting in Fiscal Year 2015 (which begins on
October 1, 2014).

The deadlines for review depend on whether a PAS requires an inspection.

Audience and Scope
Guidance is narrowly tailored:
Guidance is for sponsors of abbreviated new drug applications (ANDAs)
preparing to file a prior approval supplement (PAS) on or after October 1,
2014.

Guidance does not apply to an amendment to a PAS if the PAS is submitted
prior to October 1, 2014, even if the amendment is submitted on or after
October 1, 2014.

Guidance does not apply to new drug applications (NDAs) or biologics
license applications (BLAs).

Guidance does not apply to supplements filed for NDAs or BLAs, nor does it
apply to changes-being effected (CBE) supplements or annual report filings
for NDAs, BLAs, and ANDAs.

Purpose of the Guidance
Describes how the GDUFA performance metric goals apply in the context
of the PAS process.

Explains how various procedures applicable to a PAS may impact the
performance goal date.
Refuse-to-Receive Standards
Inspections
Amendments
Grouped Supplements/Incorrect Reporting Category

GDUFA Performance Metrics
Performance Metric Goals for PASs:

Inspection not needed 6 month goal
Inspection needed 10 month goal
Review and Act on
60% of PAS submissions in FY 2015
75% of PAS submissions in FY 2016
90% of PAS submissions in FY 2017

GDUFA Performance Metrics Calculating Goal
Dates
The submission date is the first day of the review period.

We calculate the goal date in months.

For example, if a complete PAS that does not require an inspection is submitted
on November 3, 2014, its 6-month GDUFA goal date for review and action by the
Agency is May 2, 2015.

We will provide the applicant with notice of the GDUFA goal date.

Filing an amendment to a PAS can revise the goal date associated with that PAS.

Procedures Impacting the GDUFA Goal Date
RTR Standards

If FDA refuses to receive a PAS, the GDUFA review clock stops.

The applicant can submit a correct or new prior approval
supplement but it will require a new GDUFA user fee.

Upon satisfaction of all applicable user fee obligations, we will issue
correspondence indicating the adjusted receipt date, which results
in a new GDUFA goal date for that PAS.

Procedures Impacting the GDUFA Goal Date
Inspections
Describes how the Agencys inspection process is applied in determining the
GDUFA goal date for a PAS.

Explains that whether an inspection is required for a PAS is within the discretion
of the Agency and will depend on the nature of the supplement.

Explains that in some circumstances it will be clear that an inspection is required
and a 10-month goal date will apply. But, in many cases a PAS will not require an
inspection and will have a 6-month goal date. There may also be some
circumstances in which the goal date may change if it is later determined that an
actual inspection is required, or not required. We will provide notice to the
applicant if such a change occurs.

Explains that FDA will continue the practice of using a risk-based assessment in
determining the need for an inspection.
Procedures Impacting the GDUFA Goal Date
Amendments to a PAS
The Agency encourages applicants to submit supplements that are
complete and ready for review, and to minimize the need for
modifications to such supplements.

If an amendment is made to a PAS, the GDUFA goal date associated with
that PAS may be revised.

This draft guidance briefly describes the amendment tiers outlined in the
Commitment Letter, but directs the reader to the Agencys companion
draft guidance for industry , ANDA Submissions Amendments and Easily
Correctable Deficiencies Under GDUFA being issued concurrently with this
guidance for more information on amendments made under GDUFA.

Procedures Impacting the GDUFA Goal Date
Amendments to a PAS
Example of how an amendment to a PAS can have an impact on the GDUFA
goal date for that PAS:
If a Tier 1 major amendment with a 10-month metric is submitted on 2/1/16 in
response to a complete response letter for a PAS, this establishes a new GDUFA
goal date of 10 months from the date of submission of the major amendment
for that PAS. The new goal date is 11/30/16.
If an amendment is made to a PAS prior to agency action on the PAS, it may
adjust the GDUFA goal date for that PAS. For example:
A PAS with a 6-month metric was submitted on 1/8/15 and given a goal date of
7/7/15. A Tier 1 delaying amendment with a 3-month metric is submitted in month 5 of
the original review cycle on 5/19/15. Submission of the amendment adjusts the GDUFA
review clock and extends the goal date 3 months from 5/19/15, the date of submission
of the amendment for that PAS. The new goal date is 8/18/15.

Procedures Impacting the GDUFA Goal Date
Other Matters
Grouped Supplements
Each PAS in a group of supplements is treated as its own individual
submission and therefore would require a GDUFA PAS fee for each
ANDA identified in the group. If the grouped submission includes only
one fee, then only the lead submission will be received.
This deficiency may result in different GDUFA goal dates for the lead
supplement and subsequently filed supplements.
ANDA sponsors have the option to submit a PAS with a comparability
protocol that may result in a PAS required for the initial submission,
with a reduced reporting category (e.g., CBE-30) for future reporting
changes covered by the approved comparability protocol.
The GDUFA performance metrics and user fees would apply to the initial
PAS, but not to the future supplements submitted under the reduced
reporting category.

Procedures Impacting the GDUFA Goal Date
Other Matters
Incorrect Reporting Category

The draft guidance explains that if the agency finds that a supplement
submitted as a CBE should have been submitted as a PAS, it will notify
the applicant explaining that the applicants submission is not accepted
as a CBE supplement.

The applicant may resubmit the supplement as a PAS for FDA approval.
The GDUFA performance metric goals and applicable user fees will
apply to that PAS. The GDUFA review clock will start from the date of
submission of that PAS.

Implementation
This guidance is being issued in July 2014 to provide industry with
information relevant to PAS submissions under GDUFA prior to the FY2015
start date.

This is a draft guidance and industry will have an opportunity for notice
and comment (60 days).

Please submit any comments on the guidance to the public docket:
FDA-2014-D-0901

Electronic comments may be submitted at www.regulations.gov.

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