Postapproval Changes for Drugs: A Practical Guide
5
Change in Applicant Name/Address
Changes to an applicant’s name in the absence
of a change of ownership are rare. However, if
such changes do occur or if the address of record
changes, they would not be expected to have an
adverse impact on product identity, purity, safety,
efficacy, or quality. As such, applicants can notify
FDA of these changes via the MA annual report.
See the NDA/ANDA and BLA annual report
regulations at 21 CFR 314.70(d), 314.81(b)(2),
and 601.12(d) for the applicable content/format
requirements for an MA annual report. As noted,
detailed information about the content and
format requirements for MA annual reports is
provided elsewhere in this book.
Note: Changes to an applicant’s name or
address would likely provoke changes to the
labeling. The regulatory requirements for postap-
proval labeling changes are addressed elsewhere
in this book. Changes to an applicant’s name or
address should also prompt notification of the
change to FDA’s drug registration and listing
system, in accordance with Section 521 of the
FD&C Act, as well as 21 CFR Part 207.
Change in Drug Master File (DMF) Holder6
If circumstances prompt a change in the holder
of a DMF, the current holder should notify FDA
(along with the people authorized to reference
the DMF) in writing. This notification should
include:
• Name of transferee
• Address of transferee
• Name of responsible official of transferee
• Effective date of transfer
• Signature of the transferring official
• Typewritten name and title of the transfer-
ring official
The new holder should submit a letter of
acceptance of the transfer and an update of
the information contained in the DMF, where
appropriate. This submission also should include
a description of any changes relating to the new
ownership (e.g., plant location and methods). The
new DMF holder shall issue an updated letter of
access to the MAH.
Administrative Changes Impacting Multiple
MAs
It is not uncommon for an administrative change
to impact multiple MAs. For example, in the
event of a corporate merger or acquisition, there
would likely be multiple products with revised
labeling (i.e., to reflect the new corporate brand-
ing and company name) described in subsequent
annual reports as a result. FDA has processes and
recommendations that describe how applicants
are to notify FDA of grouped product qual-
ity changes.7 In essence, these processes and
recommendations also can be applied to grouped
administrative changes, i.e., submissions should
clearly describe the change and cross-reference
all related submissions to other MAs. Consider
contacting the appropriate review division for
situation-specific advice before submitting any
grouped set of administrative changes.
Other Administrative Changes
MA Withdrawal—Applicant-Initiated
If an applicant elects to withdraw one or more
of its MAs voluntarily, usually in cases where
marketing of the associated product(s) has been
permanently discontinued (e.g., for commercial
reasons) but sometimes in response to an FDA
request or in anticipation of an adverse regulatory
action, this process can be initiated with corre-
spondence to the relevant FDA review division. A
correspondence requesting withdrawal of an MA
is considered to have been submitted voluntarily,
and the applicant waives its right to a hearing.
• As noted in 21 CFR 314.150(c),8 FDA will
withdraw approval of an NDA or ANDA
at the applicant’s request because the drug
subject to the application or abbreviated
application is no longer being marketed, pro-
vided none of the listed situations described
in 21 CFR 314.150 (a) or (b) apply.
• Similarly, 21 CFR 601.59 provides for
FDA to revoke a biologics license if the
manufacturer gives notice of the intent to
discontinue manufacture of all products
manufactured under that license or to
discontinue the manufacture of a particular
product for which a license is held.
5
Change in Applicant Name/Address
Changes to an applicant’s name in the absence
of a change of ownership are rare. However, if
such changes do occur or if the address of record
changes, they would not be expected to have an
adverse impact on product identity, purity, safety,
efficacy, or quality. As such, applicants can notify
FDA of these changes via the MA annual report.
See the NDA/ANDA and BLA annual report
regulations at 21 CFR 314.70(d), 314.81(b)(2),
and 601.12(d) for the applicable content/format
requirements for an MA annual report. As noted,
detailed information about the content and
format requirements for MA annual reports is
provided elsewhere in this book.
Note: Changes to an applicant’s name or
address would likely provoke changes to the
labeling. The regulatory requirements for postap-
proval labeling changes are addressed elsewhere
in this book. Changes to an applicant’s name or
address should also prompt notification of the
change to FDA’s drug registration and listing
system, in accordance with Section 521 of the
FD&C Act, as well as 21 CFR Part 207.
Change in Drug Master File (DMF) Holder6
If circumstances prompt a change in the holder
of a DMF, the current holder should notify FDA
(along with the people authorized to reference
the DMF) in writing. This notification should
include:
• Name of transferee
• Address of transferee
• Name of responsible official of transferee
• Effective date of transfer
• Signature of the transferring official
• Typewritten name and title of the transfer-
ring official
The new holder should submit a letter of
acceptance of the transfer and an update of
the information contained in the DMF, where
appropriate. This submission also should include
a description of any changes relating to the new
ownership (e.g., plant location and methods). The
new DMF holder shall issue an updated letter of
access to the MAH.
Administrative Changes Impacting Multiple
MAs
It is not uncommon for an administrative change
to impact multiple MAs. For example, in the
event of a corporate merger or acquisition, there
would likely be multiple products with revised
labeling (i.e., to reflect the new corporate brand-
ing and company name) described in subsequent
annual reports as a result. FDA has processes and
recommendations that describe how applicants
are to notify FDA of grouped product qual-
ity changes.7 In essence, these processes and
recommendations also can be applied to grouped
administrative changes, i.e., submissions should
clearly describe the change and cross-reference
all related submissions to other MAs. Consider
contacting the appropriate review division for
situation-specific advice before submitting any
grouped set of administrative changes.
Other Administrative Changes
MA Withdrawal—Applicant-Initiated
If an applicant elects to withdraw one or more
of its MAs voluntarily, usually in cases where
marketing of the associated product(s) has been
permanently discontinued (e.g., for commercial
reasons) but sometimes in response to an FDA
request or in anticipation of an adverse regulatory
action, this process can be initiated with corre-
spondence to the relevant FDA review division. A
correspondence requesting withdrawal of an MA
is considered to have been submitted voluntarily,
and the applicant waives its right to a hearing.
• As noted in 21 CFR 314.150(c),8 FDA will
withdraw approval of an NDA or ANDA
at the applicant’s request because the drug
subject to the application or abbreviated
application is no longer being marketed, pro-
vided none of the listed situations described
in 21 CFR 314.150 (a) or (b) apply.
• Similarly, 21 CFR 601.59 provides for
FDA to revoke a biologics license if the
manufacturer gives notice of the intent to
discontinue manufacture of all products
manufactured under that license or to
discontinue the manufacture of a particular
product for which a license is held.