Section I: Marketing Authorization Transfers, Renewals, and Administrative Changes
Chapter 1: United States
4
An ANDA contains data submitted to FDA
for the review and potential approval of a generic
drug product. A generic drug product is one that
is comparable to an innovator drug product in
dosage form, strength, route of administration,
quality, performance characteristics, and intended
use. Applicable regulations are in 21 CFR Parts
314 and 320.3 Generic drugs are regulated under
section 505(j) of the FD&C Act.
Applicable Regulatory Requirements
Where application type-specific regulations,
guidances, or other policy documents apply, they
are noted below. Otherwise, general recom-
mended best practices are provided, and the
term “MA” will be used to encompass all three
application types.
MA Transfer
There are several circumstances that can cause
ownership of an MA to be transferred, including
by sale, from one applicant to another. For exam-
ple, pharmaceutical companies can decide to
cease all development and commercialization in
a particular therapeutic area for business reasons.
As previously indicated, a key regulatory princi-
ple is maintaining an accurate MA, which would
include accurate contact information, at all times.
For an NDA or an ANDA, the regulations
at 21 CFR 314.72 require submission of the fol-
lowing information to FDA at the time an MA
is transferred:4
• The former owner must submit a letter or
other document indicating that all rights to
the MA have been transferred to the new
owner.
• The new owner must submit an updated
form FDA 356h, signed by the new owner,
along with a letter or other document that
contains the new owner’s commitment to
the agreements made by the former owner
and contained in the MA, the date that the
change in ownership goes into effect, and a
statement that the new owner has a com-
plete copy of the approved MA, including
any supplements and records required to be
maintained according to 21 CFR 314.81.
(These reports include field alerts and annual
reports, discussed elsewhere in this book.)
The range of products regulated under
a BLA is very broad, including cell and gene
therapy, therapeutic proteins, vaccines, and
blood products. While, in theory, a BLA
can change ownership for the same reasons
that an NDA applicant decides to transfer
ownership, the complexity of many biologics
makes such a transfer unlikely. However, if
such a transfer is planned, while there are no
applicable regulations, the same principles
apply to this situation as for the transfer
of ownership of an NDA. Specifically,
the Center for Biologics Research and
Evaluation (CBER) has a Standard
Operating Procedures and Policies (SOPP)
document that recommends the following:5
• Changes to a US license that are required
due to changes to the applicant’s or the
product’s ownership will be handled as
administrative actions through product
correspondence. The information regarding
the new applicant, including changes to the
labeling, will be reviewed by the responsible
product office.
• The submission for a change in appli-
cant or product ownership should include
the following in the cover letter: the new
applicant’s name, any changes in personnel,
manufacturing, standard operating proce-
dures, and manufacturing facilities.
• If the name change is due to a corporate buy
out, two submissions are needed.
• One submission should be from the appli-
cant being bought. The cover letter should
include information (e.g., name, address,
existing license number, if applicable) on
who is buying the applicant.
• The other submission should be from the
firm buying the applicant. The cover letter
should include information (e.g., name,
address, license number, if applicable) on the
applicant they are buying and the products
that are being bought. (Ideally, the submis-
sions should be coordinated, so they can be
processed at the same time.)
Chapter 1: United States
4
An ANDA contains data submitted to FDA
for the review and potential approval of a generic
drug product. A generic drug product is one that
is comparable to an innovator drug product in
dosage form, strength, route of administration,
quality, performance characteristics, and intended
use. Applicable regulations are in 21 CFR Parts
314 and 320.3 Generic drugs are regulated under
section 505(j) of the FD&C Act.
Applicable Regulatory Requirements
Where application type-specific regulations,
guidances, or other policy documents apply, they
are noted below. Otherwise, general recom-
mended best practices are provided, and the
term “MA” will be used to encompass all three
application types.
MA Transfer
There are several circumstances that can cause
ownership of an MA to be transferred, including
by sale, from one applicant to another. For exam-
ple, pharmaceutical companies can decide to
cease all development and commercialization in
a particular therapeutic area for business reasons.
As previously indicated, a key regulatory princi-
ple is maintaining an accurate MA, which would
include accurate contact information, at all times.
For an NDA or an ANDA, the regulations
at 21 CFR 314.72 require submission of the fol-
lowing information to FDA at the time an MA
is transferred:4
• The former owner must submit a letter or
other document indicating that all rights to
the MA have been transferred to the new
owner.
• The new owner must submit an updated
form FDA 356h, signed by the new owner,
along with a letter or other document that
contains the new owner’s commitment to
the agreements made by the former owner
and contained in the MA, the date that the
change in ownership goes into effect, and a
statement that the new owner has a com-
plete copy of the approved MA, including
any supplements and records required to be
maintained according to 21 CFR 314.81.
(These reports include field alerts and annual
reports, discussed elsewhere in this book.)
The range of products regulated under
a BLA is very broad, including cell and gene
therapy, therapeutic proteins, vaccines, and
blood products. While, in theory, a BLA
can change ownership for the same reasons
that an NDA applicant decides to transfer
ownership, the complexity of many biologics
makes such a transfer unlikely. However, if
such a transfer is planned, while there are no
applicable regulations, the same principles
apply to this situation as for the transfer
of ownership of an NDA. Specifically,
the Center for Biologics Research and
Evaluation (CBER) has a Standard
Operating Procedures and Policies (SOPP)
document that recommends the following:5
• Changes to a US license that are required
due to changes to the applicant’s or the
product’s ownership will be handled as
administrative actions through product
correspondence. The information regarding
the new applicant, including changes to the
labeling, will be reviewed by the responsible
product office.
• The submission for a change in appli-
cant or product ownership should include
the following in the cover letter: the new
applicant’s name, any changes in personnel,
manufacturing, standard operating proce-
dures, and manufacturing facilities.
• If the name change is due to a corporate buy
out, two submissions are needed.
• One submission should be from the appli-
cant being bought. The cover letter should
include information (e.g., name, address,
existing license number, if applicable) on
who is buying the applicant.
• The other submission should be from the
firm buying the applicant. The cover letter
should include information (e.g., name,
address, license number, if applicable) on the
applicant they are buying and the products
that are being bought. (Ideally, the submis-
sions should be coordinated, so they can be
processed at the same time.)