Guidance for Industry on Immunogenicity Assessment for Therapeutic Protein Products; Availability, 47649-47650 [2014-19267]
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Federal Register / Vol. 79, No. 157 / Thursday, August 14, 2014 / Notices
47649
Application No.
Drug
Applicant
NDA 016418 ..............
INDERAL (propranolol HCl) Tablet; Oral, 80 mg .................
NDA 016909 ..............
LIDEX (fluocinonide) Ointment; Topical 0.05% ...................
NDA 017373 ..............
NDA 020073 ..............
LIDEX (fluocinonide) Gel; Topical 0.05% ............................
ROMAZICON (flumazenil) Injectable; Injection, 1 mg/10
milliliters (mL) (0.1 mg/mL); 0.5 mg/5 mL (0.1 mg/mL).
LEUSTATIN (cladribine) Injectable; Injection, 1 mg/mL ......
Wyeth Pharmaceuticals Inc., C/O Pfizer Inc., 235 East
42nd St., New York, NY 10017.
County Line Pharmaceuticals, LLC, 13890 Bishop’s Dr.,
Suite 410, Brookfield, WI 53005.
.....Do.
Hoffmann-La Roche Inc., C/O Genentech Inc., 1 DNA
Way, South San Francisco, CA 94080–4990.
Janssen Pharmaceuticals Inc., C/O Johnson and Johnson
Pharmaceutical Research and Development LLC, 920
Rt. 202 South, P.O. Box 300, Raritan, NJ 08869.
Abbott Laboratories Pharmaceutical Products Division,
Dept. 491 AP6B 1, Abbott Park, IL 60064.
Merck and Co. Inc., 126 East Lincoln Ave., RY 33 212,
P.O. Box 2000, Rahway, NJ 07065–0900.
NDA 020229 ..............
NDA 020347 ..............
NDA 020560 ..............
NDA 020813 ..............
NDA 021046 ..............
NDA 022246 ..............
NDA 050533 ..............
HYTRIN (terazosin HCl) Capsule; Oral, EQ 1 mg Base;
EQ 2 mg Base; EQ 5 mg Base; EQ 10 mg Base.
FOSAMAX (alendronate sodium) Tablet; Oral, EQ 5 mg
Base; EQ 10 mg Base; EQ 35 mg Base; EQ 40 mg
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KLONOPIN (clonazepam) Tablet, Orally Disintegrating
Tablet (ODT); Oral, 0.125 mg, 0.25 mg, 0.5 mg, 1 mg, 2
mg.
CELEXA (citalopram hydrobromide) Solution; Oral, EQ 10
mg Base/5 mL.
METOZOLV ODT (metoclopramide HCl) Tablet, ODT;
Oral, EQ 10 mg Base.
VIBRA–TABS (doxycycline hyclate) Tablet; Oral, EQ 100
mg Base.
FDA has reviewed its records and,
under § 314.161, has determined that
the drug products listed in this
document were not withdrawn from
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effectiveness. Accordingly, the Agency
will continue to list the drug products
listed in this document in the
‘‘Discontinued Drug Product List’’
section of the Orange Book. The
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identifies, among other items, drug
products that have been discontinued
from marketing for reasons other than
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Approved ANDAs that refer to the
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those NDAs. Additional ANDAs that
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approved by the Agency if they comply
with relevant legal and regulatory
requirements. If FDA determines that
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be revised to meet current standards, the
Agency will advise ANDA applicants to
submit such labeling.
Dated: August 8, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
tkelley on DSK3SPTVN1PROD with NOTICES
[FR Doc. 2014–19272 Filed 8–13–14; 8:45 am]
BILLING CODE 4164–01–P
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Jkt 232001
Hoffmann-La Roche Inc., 340 Kingsland St., Nutley, NJ
07110.
Forest Laboratories Inc., Harborside Financial Center,
Plaza V, Suite 1900, Jersey City, NJ 07311.
Salix Pharmaceuticals Inc., 8510 Colonnade Center Dr.,
Raleigh, NC 27615.
Pfizer Laboratories Inc., 235 East 42nd St., New York, NY
10017.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–D–0092]
Guidance for Industry on
Immunogenicity Assessment for
Therapeutic Protein Products;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or the Agency) is
announcing the availability of a
guidance for industry entitled
‘‘Immunogenicity Assessment for
Therapeutic Protein Products.’’
Therapeutic protein products may elicit
immune responses, which may lead to
serious or life-threatening adverse
events for the patient or loss of efficacy
of the product. This guidance is
intended to assist manufacturers and
clinical investigators in developing a
risk-based approach in both the
nonclinical and clinical phases of
product development that will allow
them to evaluate and reduce the
likelihood that the immunogenicity of
the product will cause harm to patients.
This guidance finalizes the draft
guidance issued in February 2013.
DATES: Submit either electronic or
written comments on Agency guidances
at any time.
ADDRESSES: Submit written requests for
single copies of this guidance to the
Division of Drug Information, Center for
SUMMARY:
PO 00000
Frm 00038
Fmt 4703
Sfmt 4703
Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 2201,
Silver Spring, MD 20993–0002; or the
Office of Communication, Outreach and
Development, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128,
Silver Spring, MD 20993–0002. 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:
Amy Rosenberg, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 2238,
Silver Spring, MD 20892, 240–402–
9789; or Stephen Ripley, Center for
Biologics Evaluation and Research,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm.
7301, Rockville, MD 20993, 240–402–
7911.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a guidance for industry entitled
‘‘Immunogenicity Assessment for
Therapeutic Protein Products.’’ The
purpose of this guidance is to assist
E:\FR\FM\14AUN1.SGM
14AUN1
47650
Federal Register / Vol. 79, No. 157 / Thursday, August 14, 2014 / Notices
tkelley on DSK3SPTVN1PROD with NOTICES
manufacturers and clinical investigators
involved in the development of
therapeutic protein products for human
use in evaluating and reducing the risk
of adverse events caused by immune
responses to these products. The
guidance: (1) Outlines and recommends
adoption of a risk-based approach to
evaluating and mitigating potential
immune responses to therapeutic
protein products that may affect their
safety and efficacy, (2) describes various
product- and patient-specific factors
that affect the immunogenicity of or
immune responses to therapeutic
protein products and provides
recommendations pertaining to each
factor that may reduce the likelihood
that an immune response will be
generated to the product, (3) offers a
series of recommendations for risk
mitigation in the clinical phase of
development of therapeutic protein
products, (4) provides supplemental
information on the diagnosis and
management of particular adverse
consequences of immune responses to
therapeutic protein products, and (5)
discusses briefly the use of animal
studies and the conduct of comparative
immunogenicity studies.
In the Federal Register of February
11, 2013 (78 FR 9702), FDA announced
the availability of the draft guidance of
the same title dated February 2013. FDA
received numerous comments on the
draft guidance, and those comments
were considered as the guidance was
finalized. In addition, editorial changes
were made to improve clarity.
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the Agency’s
current thinking on immunogenicity
assessments for therapeutic protein
products. 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 either
electronic comments regarding this
document to https://www.regulations.gov
or written comments to the Division of
Dockets Management (see ADDRESSES). 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, and
will be posted to the docket at https://
www.regulations.gov.
VerDate Mar<15>2010
16:42 Aug 13, 2014
Jkt 232001
III. Electronic Access
Persons with access to the Internet
may obtain the document at https://
www.fda.gov/Drugs/
GuidanceCompliance
RegulatoryInformation/Guidances/
default.htm; https://www.fda.gov/
BiologicsBloodVaccines/
GuidanceCompliance
RegulatoryInformation/Guidances/
default.htm; or https://
www.regulations.gov.
Dated: August 8, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–19267 Filed 8–13–14; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–1108]
Revised Draft Guidance for Industry on
Clinical Pharmacology Labeling for
Human Prescription Drug and
Biological Products—Considerations,
Content, and Format; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a revised draft guidance
for industry entitled ‘‘Clinical
Pharmacology Labeling for Human
Prescription Drug and Biological
Products—Considerations, Content, and
Format.’’ This draft guidance is one of
a series of guidance documents
intended to assist applicants in
complying with FDA regulations on the
content and format of labeling for
human prescription drug and biological
products. The guidance describes the
recommended information to include in
the Clinical Pharmacology section of
labeling that pertains to the safe and
effective use of human prescription drug
and biological products. This revised
draft guidance replaces the 2009 draft
guidance for industry entitled ‘‘Clinical
Pharmacology Section of Labeling for
Human Prescription Drug and Biological
Products—Content and Format.’’
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the draft guidance by October 14,
2014.
SUMMARY:
PO 00000
Frm 00039
Fmt 4703
Sfmt 4703
Submit written requests for
single copies of the draft 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, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128,
Silver Spring, MD 20993. Send one selfaddressed adhesive label to assist that
office in processing your requests. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the draft
guidance document.
Submit electronic comments on the
draft 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: Lei
Zhang, Office of Clinical Pharmacology,
Office of Translational Sciences, Center
for Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 3177,
Silver Spring, MD 20993–0002, 301–
796–5008 or Stephen Ripley, Center for
Biologics Evaluation and Research,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm.
7301, Silver Spring, MD 20993–0002,
240–402–7911.
SUPPLEMENTARY INFORMATION:
ADDRESSES:
I. Background
In the Federal Register of January 24,
2006 (71 FR 3922), FDA published a
final rule entitled ‘‘Requirements on
Content and Format of Labeling for
Human Prescription Drug and Biological
Products’’ to revise the Agency’s
previous regulations on labeling
(effective June 30, 2006). The final rule,
commonly referred to as the Physician
Labeling Rule (PLR), is designed to
make information in prescription drug
labeling easier for health care
practitioners to access, read, and use,
thereby increasing the extent to which
practitioners rely on labeling for
prescribing decisions. In the Federal
Register of March 3, 2009 (74 FR 9250),
FDA announced the availability of a
draft guidance for industry entitled
‘‘Clinical Pharmacology Section of
Labeling for Human Prescription Drug
and Biological Products—Content and
Format’’ as one of a series of guidance
documents intended to assist applicants
in complying with FDA regulations on
the content and format of labeling for
human prescription drug and biological
E:\FR\FM\14AUN1.SGM
14AUN1
Agencies
[Federal Register Volume 79, Number 157 (Thursday, August 14, 2014)]
[Notices]
[Pages 47649-47650]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-19267]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-D-0092]
Guidance for Industry on Immunogenicity Assessment for
Therapeutic Protein Products; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or the Agency) is
announcing the availability of a guidance for industry entitled
``Immunogenicity Assessment for Therapeutic Protein Products.''
Therapeutic protein products may elicit immune responses, which may
lead to serious or life-threatening adverse events for the patient or
loss of efficacy of the product. This guidance is intended to assist
manufacturers and clinical investigators in developing a risk-based
approach in both the nonclinical and clinical phases of product
development that will allow them to evaluate and reduce the likelihood
that the immunogenicity of the product will cause harm to patients.
This guidance finalizes the draft guidance issued in February 2013.
DATES: Submit either electronic or written comments on Agency guidances
at any time.
ADDRESSES: Submit written requests for single copies of this 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 the Office of
Communication, Outreach and Development, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. 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: Amy Rosenberg, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 2238, Silver Spring, MD 20892, 240-402-
9789; or Stephen Ripley, Center for Biologics Evaluation and Research,
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm.
7301, Rockville, MD 20993, 240-402-7911.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a guidance for industry
entitled ``Immunogenicity Assessment for Therapeutic Protein
Products.'' The purpose of this guidance is to assist
[[Page 47650]]
manufacturers and clinical investigators involved in the development of
therapeutic protein products for human use in evaluating and reducing
the risk of adverse events caused by immune responses to these
products. The guidance: (1) Outlines and recommends adoption of a risk-
based approach to evaluating and mitigating potential immune responses
to therapeutic protein products that may affect their safety and
efficacy, (2) describes various product- and patient-specific factors
that affect the immunogenicity of or immune responses to therapeutic
protein products and provides recommendations pertaining to each factor
that may reduce the likelihood that an immune response will be
generated to the product, (3) offers a series of recommendations for
risk mitigation in the clinical phase of development of therapeutic
protein products, (4) provides supplemental information on the
diagnosis and management of particular adverse consequences of immune
responses to therapeutic protein products, and (5) discusses briefly
the use of animal studies and the conduct of comparative immunogenicity
studies.
In the Federal Register of February 11, 2013 (78 FR 9702), FDA
announced the availability of the draft guidance of the same title
dated February 2013. FDA received numerous comments on the draft
guidance, and those comments were considered as the guidance was
finalized. In addition, editorial changes were made to improve clarity.
This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
Agency's current thinking on immunogenicity assessments for therapeutic
protein products. 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 either electronic comments regarding
this document to https://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). 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, and will be posted to the docket at https://www.regulations.gov.
III. Electronic Access
Persons with access to the Internet may obtain the document at
https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm; https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm; or
https://www.regulations.gov.
Dated: August 8, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-19267 Filed 8-13-14; 8:45 am]
BILLING CODE 4164-01-P