GUDFA –II Goals for ANDA Reviews
|
The GDUFA II (fiscal years 2018-2022) commitment letter describes a
consolidated review scheme for all cohorts of abbreviated new drug applications
(ANDAs).USFDA targets to review ANDA applications as detailed below.
Submission Type
|
Goal
|
Original
ANDAs
|
|
Standard Original ANDAs
|
90% within 10
months of submission date.
|
Priority Original ANDAs
|
Within 8
months, provided the applicant, not later than 60 days prior to the
submission of an application, provides as required by 21 U.S.C. 355(j)
Complete and
accurate information regarding facilities involved in manufacturing processes
and testing of the drug that is the subject of the application; and
The
information remains unchanged relative to the date of the submission of the
application
|
Within 10
months of submission date if:
The applicant
does not identify the submission as eligible for prioritization pursuant to FDA’s prioritization criteria, or FDA determines it does not
appear to meet the prioritization criteria.
The applicant
does not pre-submit facility information, or the facility information changes
or is found to be incomplete or inaccurate.
|
|
ANDA
Amendments
|
|
Standard
Major ANDA Amendments
|
Within 8
months of submission date if preapproval inspection not required.
|
Within 10
months of submission date if preapproval inspection required.
|
|
Priority Major
ANDA Amendments
|
Within 6 months
of submission date if preapproval inspection not required.
|
Within 8 months, provided
the applicant, not later than 60 days prior to the submission of an
application, provides as required by 21 U.S.C. 355(j)
Complete and accurate
information regarding facilities involved in manufacturing processes and
testing of the drug that is the subject of the application; and
|
|
Within 10 months of submission date if:
|
|
Standard and Priority Minor
ANDA Amendments
|
Within 3 months of
submission date.
|
Prior
Approval Supplements
|
|
Standard PASs
|
Within 6 months of
submission date if preapproval inspection not required.
|
Within 10 months of
submission date if preapproval inspection required.
|
|
Priority PASs
|
Within 4 months of
submission date if preapproval inspection not required.
|
Within 8 months, provided
the applicant, not later than 60 days prior to the submission of an
application, provides as required by 21 U.S.C. 355(j)
|
|
Within 10 months of submission date if:
|
|
Prior
Approval Supplements Amendments
|
|
Standard PAS Major Amendments
|
Within 6 months of
submission date if preapproval inspection not required.
|
Within 10 months of
submission date if preapproval inspection required.
|
|
Priority PAS Amendments
|
Within 4 months of submission
date if preapproval inspection not required.
|
Within 8 months, provided
the applicant, not later than 60 days prior to the submission of an
application, provides as required by 21 U.S.C. 355(j)
|
|
Within 10 months of
submission date if:
|
|
Standard and Priority Minor PAS
Amendments
|
Within 3 months of
submission date.
|
Criteria for
Priority Review
1. Submissions
containing certain patent certifications and exclusivity statements
- Submissions for drug
products for which there are not more than three approved drug products
listed in FDA’s Approved Drug Products with Therapeutic Equivalence
Evaluations (the “Orange Book”) and for which there are no blocking
patents or exclusivities listed for the reference listed drug (RLD) may
receive a priority review.
- Submissions that
contain a paragraph IV certification but become eligible for approval
during the review period as a result of no blocking patents or
exclusivities (including 180-day exclusivity under section 505(j)(5)(B) of
the FD&C Act (180-day exclusivity)) and no applicable stays may
receive a priority review if no other generic version of the same RLD has
been brought to market under an approved ANDA. The absence of any blocking
patent, exclusivity period, or stay must be appropriately documented in
order for a priority review to be granted. For 180-day exclusivity, “no exclusivity”
means that the 180-day exclusivity has either been relinquished or waived
or that FDA has determined that a forfeiture of the exclusivity has
occurred.
- Submissions that contain
a paragraph IV certification, are submitted on the first day that any
valid paragraph IV application for the drug in question is submitted, and are
received as substantially complete (i.e., submissions that have “first
filer” status) may receive a priority review.
- Submissions for drug
products blocked by 180-day exclusivity that have been tentatively
approved or submissions for drug products blocked by 180-day exclusivity
that OGD determines will likely be ready for approval upon or shortly
after expiration of the 180-day exclusivity may receive a priority review
when such exclusivity is triggered.
2.
Submissions related to drug shortages
Submissions that could help
mitigate or resolve a drug shortage and prevent future shortages, including
submissions related to products that are listed on FDA’s Current Drug Shortages
Index at the time of the submission, may receive a priority review.
3. Submissions
that are subject to special review programs such as the President’s Emergency
Plan for AIDS Relief
Submissions in this category
may receive a priority review.
4.
Submissions related to public health emergencies
Submissions that either
could help address a public health emergency declared by the Secretary of the
U.S. Department of Health and Human Services, or anticipated under the same
criteria as apply to such a declaration, may receive a priority review.
5.
Submissions related to certain government purchasing programs
Submissions related to certain government
purchasing or procurement activities, including expiration-date extensions or
packaging changes usually requested by the Government-Wide Quality Assurance
Program, may receive a priority review.
6.
Submissions subject to statutory mandates or other legal requirements
Submissions that are
subject to federal or state mandates or other legal or regulatory actions may
receive a priority review as necessary to comply with those requirements. Note:
This category includes legally required changes in formulation or labeling.
However, supplements submitted following actions taken by FDA field staff
against applicants who put changes into effect that are required to have
approved supplements under 21 CFR 314.70 will not be considered for a priority
review.
7.
Supplements for which a priority review is requested under 21 CFR 314.70(b)
Under 21 CFR 314.70(b), an
applicant may ask FDA to grant a priority review to “a supplement for public
health reasons or if a delay in making the change described in [the supplement]
would impose an extraordinary hardship on the applicant.” For priority reviews,
“extraordinary hardship on the applicant” will be interpreted to include the
following:
i.
Catastrophic events such as explosion,
fire, or storm damage to manufacturing facilities.
ii.
Events
that could not have been reasonably foreseen by the applicant and for which the
applicant could not have planned. Examples include:
1. An abrupt discontinuation of the supply of an active ingredient,
packaging material, or container closure system.
2. The relocation of a facility or a change in an existing facility
because of a catastrophic event. (In the absence of a catastrophic event, the
applicant should contact OGD early in the planning stage of a contemplated
relocation or change.)
8.
Submissions for “sole source” drug products
Submissions for drug products for which there
is only one approved drug product listed in the Prescription Drug Product List
(i.e., the “active section”) of the Orange Book and for which there are no
blocking patents or exclusivities may receive a priority review, except when
the approved drug product was approved pursuant to a suitability petition under
section 505(j)( C) of the FD&C Act.
If approval of a submission
either is dependent on the expiration of a patent (i.e., the submission
contains a paragraph III certification) or is dependent on the expiration of an
exclusivity period, OGD and OPQ will seek to complete the review of the
submission in a manner that would permit approval by the last applicable patent
expiration date or exclusivity date. However, with regard to ANDAs submitted on
or after October 1, 2014:
i.
ANDAs submitted within 1 year of the last
applicable patent expiration date or exclusivity date will not be considered
for priority review, and FDA can provide no assurances that the review will be
completed in a manner that would permit approval by the last applicable patent
expiration date or exclusivity date. However, this provision may be subject to
an exception when it is determined that the submission should be granted a
priority review to address a public health concern. These determinations will
be made by the OGD regulatory project manager (RPM) and OGD management in
consultation with other FDA personnel as necessary.
ii.
ANDAs submitted more than 30 months in advance
of the last applicable patent expiration date or exclusivity date will not be
considered for a priority review.
FDA will only consider a
priority request when (1) the submission and cover letter clearly state
“Priority Review Requested” and reference the ANDA number (when applicable),
(2) the basis for the request is consistent with FDAs prioritization procedure,
(3) the applicant clearly and briefly states the basis of the request, and (4)
the applicant includes sufficient supporting documentation for the request.
DEFINITIONS
Expedited Review: FDA will strive to act on
an ANDA as soon as possible, including prior to the goal date if possible. An
expedited review, though, does not result in a shorter goal date.
Priority Review: FDA will either (1) give a
shorter goal date or (2) grant an expedited review.
Shorter Goal Date: In accordance with the
GDUFA II Commitment Letter, FDA commits to one of the following (1) for
original ANDAs, an 8-month goal date; (2) for major amendments, a 6- or 8-month
goal date; or (3) for prior approval supplements, a 4- or 8-month goal date.
No comments:
Post a Comment