The document outlines the types of post-approval changes in drug products, detailing required information for various supplement submissions. It specifies the timelines for both standard and priority review processes, as well as the documentation needed to facilitate processing. Additionally, it notes that as of October 1, 2017, application fees for post-approval supplements have been eliminated for ANDA applicants.

2. AreasofPost-approvalchanges
(1) composition
(2) manufacturing
sites
(3) manufacturing
process
(4) specifications
(5) container closure
system
(6) labeling
(7) multiple related
changes
Types of Post
approval
changes
Major
Need Prior
Approval
Supplement
Moderate
CBE-30
CBE-0
Minor

3. General
Requirements of
the Supplement
Must include a list
of all changes
Changes Must be
detailed
Labeling changes
must include 12
copies of the final
printed labeling

4. Types Of 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
• Within 10 months of
submission date if FDA
determines it does not
appear to meet the
prioritization criteria.
General information contained in the
supplement:
A detailed description of the proposed
change
The drug product(s) involved
The manufacturing site(s) or area(s)
affected
A description of the methods used and studies
performed to assess the effects of the change
and the data derived from such studies
Relevant validation protocols and S.O.P. for
Herbals and Biologics
Relevant validation protocols and S.O.P. for
sterilization process and test methodologies
related to it.

18. To facilitate processing, FDA recommends that the applicant provide the following
information on the first page of the submission:
A
statement
indicating
whether
the PAS is
for a new-
strength
product
A
statement
indicating
whether
the PAS is
for a
request for
proprietary
name
review.
A statement
indicating
whether the
PAS is for a
Risk
Evaluation
and
Mitigation
Strategy
(REMS) or a
REMS
modification.
A statement
indicating
whether the
submission is
an
amendment
to a PAS, and
whether it is a
major or
minor
amendment
A statement
indicating
whether the
PAS contains
any
manufacturin
g or facilities
changes
A list of the
specific review
disciplines to
review the PAS
(Chemistry,
Biopharmaceutics,
Labeling, DMF,
Bioequivalence,
Microbiology, or
Clinical)
If expedited
review is
requested, the
label Expedited
Review Request
should be placed
prominently at
the top of the
submission. The
submission
should include a
basis for the
expedited review
Any PAS to an approved ANDA should identify on the first page of the submission
that it is a PAS.

19. Fees For PAS
 GDUFA I established application fees (for ANDAs, PASs to ANDAs, and certain DMFs), annual facility
fees, and a one-time fee for ANDAs that were pending on October 1, 2012.
 As explained in the GDUFA II Commitment Letter, however, the Agency and industry agreed to the
elimination of PAS fees. As of October 1, 2017, ANDA applicants are no longer required to pay
application fees when they submit a PAS.