Guidance for Industry on Product Name Placement, Size, and Prominence in Advertising and Promotional Labeling; Availability, 3779-3780 [2012-1431]
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Federal Register / Vol. 77, No. 16 / Wednesday, January 25, 2012 / Notices
W
Warfarin Sodium
Z
Zolmitriptan
Zolpidem
srobinson on DSK4SPTVN1PROD with NOTICES
III. Drug Products for Which Revised
Draft Product-Specific BE
Recommendations Are Available
FDA is announcing revised draft BE
product-specific recommendations for
drug products containing the following
active ingredients. These
recommendations were previously
posted on the FDA’s Web site:
A
Amantadine HCl
Atorvastatin
B
Bupropion HBr
C
Calcipotriene
Calcium Acetate
Calcitriol
Capecitabine (multiple RLDs)
Cefditoren Pivoxil
Ciclopirox
Clotrimazole
Colesevelam HCl (multiple RLDs)
D
Darunavir Ethanolate
Desogestrel; Ethinyl Estradiol
Desvenlafaxine Succinate
Diclofenac Sodium
Diclofenac Sodium; Misoprostol
Disulfiram
Donepezil HCl (multiple RLDs)
E
Emtricitabine
Esomeprazole Magnesium
Estradiol
Ethinyl Estradiol; Ethynodiol Diacetate
(multiple RLDs)
Ethinyl Estradiol; Norethindrone
F
Felbamate (multiple RLDs)
Fentanyl
Fentanyl Citrate
Fluorouracil (multiple RLDs)
G
Glyburide Metformin
Granisetron HCl
L
Labetalol HCl
Lamotrigine (multiple RLDs)
Lapatinib Ditosylate
Levofloxacin
Levonorgestrel (multiple RLDs)
Linezolid
M
Memantine HCl
Mercaptopurine (multiple RLDs)
Metformin HCl (multiple RLDs)
Minoxidil
Morphine
N
Nebivolol
Niacin
VerDate Mar<15>2010
18:09 Jan 24, 2012
Jkt 226001
Nilutamide
Nitroglycerin
O
Omeprazole
Orlistat (multiple RLDs)
Oxymorphone HCl
P
Prednisolone
Progesterone
R
Rivastigmine
Rivastigmine Tartrate
Ropinirole
S
Scopolamine
Sevelamer Carbonate (multiple RLDs)
Sevelamer HCl (multiple RLDs)
Sirolimus
T
Telmisartan
Tiagabine HCl
Topiramate
Tranexamic Acid
Triamcinolone Acetonide (multiple RLDs)
V
Varenicline Tartrate
Venlafaxine HCl
For a complete history of previously
published Federal Register notices,
please go to https://www.regulations.gov
and enter docket number FDA–2007–D–
0369.
These draft and revised draft
guidances are being issued consistent
with FDA’s good guidance practices
regulation (21 CFR 10.115). The
guidances represent the Agency’s
current thinking on product-specific
design of BE studies to support ANDAs.
They do not create or confer any rights
for or on any person and do not operate
to bind FDA or the public. An
alternative approach may be used if
such approach satisfies the
requirements of the applicable statutes
and regulations.
IV. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) either electronic or written
comments on any of the specific BE
recommendations posted on FDA’s Web
site. It is only necessary to send one set
of comments. Identify comments with
the docket number found in brackets in
the heading of this document. The
guidance, notices, and received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
V. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/Drugs/
GuidanceCompliance
RegulatoryInformation/Guidances/
PO 00000
Frm 00051
Fmt 4703
Sfmt 4703
3779
default.htm or https://
www.regulations.gov.
Dated: January 19, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012–1433 Filed 1–24–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–1999–D–4079 (Formerly
Docket No. 1999D–0254)]
Guidance for Industry on Product
Name Placement, Size, and
Prominence in Advertising and
Promotional Labeling; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a guidance document
entitled ‘‘Product Name Placement,
Size, and Prominence in Advertising
and Promotional Labeling.’’ The
guidance is intended to clarify for
applicants the requirements for product
name placement, size, prominence, and
frequency in promotional labeling and
advertising for prescription human and
animal drugs and biological products.
This guidance finalizes the draft
guidance published in January 1999.
DATES: Submit either electronic or
written comments on Agency guidances
at any time.
ADDRESSES: Submit written requests for
single copies of the guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 2201,
Silver Spring, MD 20993–0002; or Office
of Communication, Outreach and
Development (HFM–40), Center for
Biologics Evaluation and Research,
Food and Drug Administration, 1401
Rockville Pike, Suite 200N, Rockville,
MD 20852–1448. Send one selfaddressed adhesive label to assist that
office in processing your requests. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the guidance
document.
Submit electronic comments on the
guidance to https://www.regulations.gov.
Submit written comments to the
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852.
FOR FURTHER INFORMATION CONTACT:
SUMMARY:
E:\FR\FM\25JAN1.SGM
25JAN1
3780
Federal Register / Vol. 77, No. 16 / Wednesday, January 25, 2012 / Notices
Regarding Human Prescription Drugs
Ernest S. Voyard, Jr., Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 Hampshire
Ave., Bldg. 51, Rm. 3276, Silver Spring,
MD 20993, (301) 796–1200.
Regarding Prescription Human
Biological Products
Stephen Ripley, Center for Biologics
Evaluation and Research (HFM–17),
Food and Drug Administration, 1401
Rockville Pike, Suite 200N, Rockville,
MD 20852–1448, (301) 827–6210.
Regarding Animal Prescription Drugs
Julie Garnier, Center for Veterinary
Medicine, Food and Drug
Administration, 7519 Standish Pl.,
Rockville, MD 20855, (240) 276–9300.
SUPPLEMENTARY INFORMATION:
srobinson on DSK4SPTVN1PROD with NOTICES
I. Background
FDA is announcing the availability of
a guidance document entitled ‘‘Product
Name Placement, Size, and Prominence
in Advertising and Promotional
Labeling.’’ This guidance discusses the
requirements for product name
placement, size, prominence, and
frequency in promotional labeling and
advertising for prescription human and
animal drugs and biological products.
The disclosure of the product name in
promotional labeling and advertising for
all prescription human and animal drug
and biological products is important for
the proper identification of such
products to ensure their safe and
effective use.
The placement, size, prominence, and
frequency of the proprietary and
established names for human and
animal prescription drug products are
specified in labeling and advertising
regulations (21 CFR 201.10(g) and (h);
202.1(b), (c), and (d)). These regulations
are also applicable to biological product
labeling and advertising materials.
The recommendations in this
guidance pertain to product names in
traditional print media promotion (e.g.,
journal ads, detail aids, brochures),
audiovisual promotional labeling (e.g.,
videos shown in a health care provider’s
office), broadcast media promotion (e.g.,
television advertisements, radio
advertisements), and electronic and
computer-based promotional labeling
and advertisements, such as Internet
promotion, social media, emails, CD–
ROMs, and DVDs.
In the Federal Register of March 12,
1999 (64 FR 12341), FDA announced the
availability of the draft guidance of the
same title, dated January 1999. FDA
received six comments on the draft
guidance, five were from the
VerDate Mar<15>2010
18:09 Jan 24, 2012
Jkt 226001
pharmaceutical industry and one was
from a consumer. The majority of the
comments related to requests to provide
additional clarifications and examples
related to the individual
recommendations in the draft guidance.
These comments were considered
carefully during the finalization of the
guidance document. The guidance has
been revised in the following ways: (1)
It clarifies certain concepts previously
discussed in the draft guidance and
adds definitions for certain terms; (2) it
provides examples to illustrate the
appropriate juxtaposition and
prominence of proprietary and
established names for products with one
active ingredient and examples to
illustrate the juxtaposition of products
with two or more active ingredients; (3)
it reorganizes and renames the draft
guidance’s sections pertaining to the
frequency of the disclosure of
proprietary and established names in
various media into one section with
three subsections—traditional print
promotional labeling and
advertisements, audiovisual
promotional labeling and broadcast
advertisements, and electronic and
computer-based promotional labeling
and advertisements; and (4) it discusses
the use of proprietary and established
names in columns in traditional print
promotional labeling and
advertisements.
The guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents FDA’s current
thinking on this topic. It does not create
or confer any rights for or on any person
and does not operate to bind FDA or the
public. An alternative approach may be
used if such approach satisfies the
requirements of the applicable statutes
and regulations.
II. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) either electronic or written
comments regarding this document. It is
only necessary to send one set of
comments. Identify comments with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
III. Electronic Access
Persons with access to the Internet
may obtain the guidance at either
https://www.fda.gov/Drugs/
GuidanceCompliance
RegulatoryInformation/Guidances/
default.htm, https://www.fda.gov/
BiologicsBloodVaccines/
PO 00000
Frm 00052
Fmt 4703
Sfmt 4703
GuidanceCompliance
RegulatoryInformation/default.htm, or
https://www.regulations.gov.
Dated: January 19, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012–1431 Filed 1–24–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0001]
Vaccines and Related Biological
Products Advisory Committee; Notice
of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). At least one portion of the
meeting will be closed to the public.
Name of Committee: Vaccines and
Related Biological Products Advisory
Committee.
General Function of the Committee:
To provide advice and
recommendations to the Agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on February 28, 2012, from
approximately 8 a.m. to 4 p.m. and
February 29, 2012, from approximately
8 a.m. to 1 p.m.
Location: FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (rm.
1503), Silver Spring MD 20993–0002.
Information regarding special
accommodations due to a disability,
visitor parking, and transportation may
be accessed at: https://www.fda.gov/
AdvisoryCommittees/default.htm; under
the heading ‘‘Resources for You’’, click
on ‘‘Public Meetings at the FDA White
Oak Campus.’’ Please note that visitors
to the White Oak Campus must enter
through Building 1.
For those unable to attend in person,
the meeting will also be webcast. The
link for the webcast is available at:
https://collaboration.fda.gov/cberac.
Contact Person: Donald W. Jehn or
Denise Royster, Center for Biologics
Evaluation and Research (HFM–71),
Food and Drug Administration, 1401
Rockville Pike Rockville, MD 20852,
(301) 827–0314, or FDA Advisory
Committee Information Line, 1-(800)
741–8138 (301) 443–0572 in the
Washington, DC area), and follow the
E:\FR\FM\25JAN1.SGM
25JAN1
]]>Agencies
[Federal Register Volume 77, Number 16 (Wednesday, January 25, 2012)]
[Notices]
[Pages 3779-3780]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-1431]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-1999-D-4079 (Formerly Docket No. 1999D-0254)]
Guidance for Industry on Product Name Placement, Size, and
Prominence in Advertising and Promotional Labeling; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guidance document entitled ``Product Name Placement,
Size, and Prominence in Advertising and Promotional Labeling.'' The
guidance is intended to clarify for applicants the requirements for
product name placement, size, prominence, and frequency in promotional
labeling and advertising for prescription human and animal drugs and
biological products. This guidance finalizes the draft guidance
published in January 1999.
DATES: Submit either electronic or written comments on Agency guidances
at any time.
ADDRESSES: Submit written requests for single copies of the guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 2201, Silver Spring, MD 20993-0002; or Office of Communication,
Outreach and Development (HFM-40), Center for Biologics Evaluation and
Research, Food and Drug Administration, 1401 Rockville Pike, Suite
200N, Rockville, MD 20852-1448. Send one self-addressed adhesive label
to assist that office in processing your requests. See the
SUPPLEMENTARY INFORMATION section for electronic access to the guidance
document.
Submit electronic comments on the guidance to https://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
[[Page 3780]]
Regarding Human Prescription Drugs
Ernest S. Voyard, Jr., Center for Drug Evaluation and Research,
Food and Drug Administration, 10903 Hampshire Ave., Bldg. 51, Rm. 3276,
Silver Spring, MD 20993, (301) 796-1200.
Regarding Prescription Human Biological Products
Stephen Ripley, Center for Biologics Evaluation and Research (HFM-
17), Food and Drug Administration, 1401 Rockville Pike, Suite 200N,
Rockville, MD 20852-1448, (301) 827-6210.
Regarding Animal Prescription Drugs
Julie Garnier, Center for Veterinary Medicine, Food and Drug
Administration, 7519 Standish Pl., Rockville, MD 20855, (240) 276-9300.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a guidance document entitled
``Product Name Placement, Size, and Prominence in Advertising and
Promotional Labeling.'' This guidance discusses the requirements for
product name placement, size, prominence, and frequency in promotional
labeling and advertising for prescription human and animal drugs and
biological products. The disclosure of the product name in promotional
labeling and advertising for all prescription human and animal drug and
biological products is important for the proper identification of such
products to ensure their safe and effective use.
The placement, size, prominence, and frequency of the proprietary
and established names for human and animal prescription drug products
are specified in labeling and advertising regulations (21 CFR 201.10(g)
and (h); 202.1(b), (c), and (d)). These regulations are also applicable
to biological product labeling and advertising materials.
The recommendations in this guidance pertain to product names in
traditional print media promotion (e.g., journal ads, detail aids,
brochures), audiovisual promotional labeling (e.g., videos shown in a
health care provider's office), broadcast media promotion (e.g.,
television advertisements, radio advertisements), and electronic and
computer-based promotional labeling and advertisements, such as
Internet promotion, social media, emails, CD-ROMs, and DVDs.
In the Federal Register of March 12, 1999 (64 FR 12341), FDA
announced the availability of the draft guidance of the same title,
dated January 1999. FDA received six comments on the draft guidance,
five were from the pharmaceutical industry and one was from a consumer.
The majority of the comments related to requests to provide additional
clarifications and examples related to the individual recommendations
in the draft guidance. These comments were considered carefully during
the finalization of the guidance document. The guidance has been
revised in the following ways: (1) It clarifies certain concepts
previously discussed in the draft guidance and adds definitions for
certain terms; (2) it provides examples to illustrate the appropriate
juxtaposition and prominence of proprietary and established names for
products with one active ingredient and examples to illustrate the
juxtaposition of products with two or more active ingredients; (3) it
reorganizes and renames the draft guidance's sections pertaining to the
frequency of the disclosure of proprietary and established names in
various media into one section with three subsections--traditional
print promotional labeling and advertisements, audiovisual promotional
labeling and broadcast advertisements, and electronic and computer-
based promotional labeling and advertisements; and (4) it discusses the
use of proprietary and established names in columns in traditional
print promotional labeling and advertisements.
The guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents FDA's
current thinking on this topic. It does not create or confer any rights
for or on any person and does not operate to bind FDA or the public. An
alternative approach may be used if such approach satisfies the
requirements of the applicable statutes and regulations.
II. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding this
document. It is only necessary to send one set of comments. Identify
comments with the docket number found in brackets in the heading of
this document. Received comments may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.
III. Electronic Access
Persons with access to the Internet may obtain the guidance at
either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm, or https://www.regulations.gov.
Dated: January 19, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-1431 Filed 1-24-12; 8:45 am]
BILLING CODE 4160-01-P
