Improving the Quality of Abbreviated New Drug Application Submissions to the Food and Drug Administration; Establishment of a Public Docket, 3828-3829 [2014-01309]
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Federal Register / Vol. 79, No. 15 / Thursday, January 23, 2014 / Notices
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: Lori
A. Bickel, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 6353, Silver Spring,
MD 20993, 301–796–0210; or 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.
SUPPLEMENTARY INFORMATION:
sroberts on DSK5SPTVN1PROD with NOTICES
I. Background
FDA is announcing the availability of
a guidance for industry and FDA staff
entitled ‘‘Dear Health Care Provider
Letters: Improving Communication of
Important Safety Information.’’ This
document offers specific guidance to
industry and FDA staff on the content
and format of DHCP letters. These
letters are sent by manufacturers or
distributors to health care providers to
communicate an important drug
warning, a change in prescribing
information, or a correction of
misinformation in prescription drug
promotional labeling or advertising.
This guidance gives specific instruction
on what should and should not be
included in DHCP letters. To date, some
DHCP letters have been too long, have
contained promotional material, or
otherwise have not met the goals set
forth in the applicable regulation (21
CFR 200.5). In some cases, health care
providers have not been aware of
important new information, and have
been unable to communicate it to
patients, because the letters’ content and
length have made it difficult to find the
relevant information. In addition, letters
have sometimes been sent for the wrong
reasons.
In addition to content and format
recommendations for each type of DHCP
letter, the guidance also includes advice
on consulting with FDA to develop a
DHCP letter, when to send a letter, what
type of letter to send, and conducting an
assessment of the letter’s impact.
In the Federal Register of November
12, 2010 (75 FR 69449), FDA announced
the availability of a draft guidance for
industry and FDA staff entitled ‘‘Dear
Health Care Provider Letters: Improving
VerDate Mar<15>2010
21:50 Jan 22, 2014
Jkt 232001
Communication of Important Safety
Information.’’ The notice gave interested
persons an opportunity to comment by
January 11, 2011. The Agency received
several comments from health care
providers, firms, and other groups. We
have carefully considered the comments
and, where appropriate, have made
corrections, added information, or
clarified information in the guidance in
response to the comments or on our
own initiative. This guidance finalizes
the draft guidance issued in November
2010.
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 ‘‘Dear Health Care
Provider Letters: Improving
Communication of Important Safety
Information.’’ 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. Paperwork Reduction Act of 1995
This guidance contains information
collection provisions that are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501–
3520). The collections of information in
this guidance were approved under
OMB control number 0910–0754.
III. 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.
IV. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm, https://
www.fda.gov/BiologicsBloodVaccines/
GuidanceComplianceRegulatory
Information/Guidances/default.htm, or
https://www.regulations.gov.
PO 00000
Frm 00054
Fmt 4703
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Dated: January 16, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–01305 Filed 1–22–14; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–0032]
Improving the Quality of Abbreviated
New Drug Application Submissions to
the Food and Drug Administration;
Establishment of a Public Docket
AGENCY:
Food and Drug Administration,
HHS.
Notice; establishment of docket;
request for comments.
ACTION:
The Food and Drug
Administration (FDA) is establishing a
public docket to receive input and
suggestions from the public on ways to
improve the quality of abbreviated new
drug applications (ANDAs) and
associated amendments and
supplements to FDA’s Office of Generic
Drugs (OGD). Specifically, FDA is
interested in hearing about any
difficulties sponsors are having
developing and preparing their ANDA
submissions that FDA could help
address, for example by providing more
or better information to industry. This
action is intended to solicit suggestions
that will improve the completeness and
quality of ANDA submissions to FDA.
FDA is also seeking input on how to
best share suggestions for improving the
quality of ANDAs with the generic drug
industry. More complete, higher quality
ANDA submissions will positively
affect the availability of low-cost, highquality generic drugs to the public.
DATES: Although FDA welcomes
comments at any time, to help FDA
address issues related to ANDA
submission quality in a timely fashion,
we encourage submission of electronic
or written comments by March 24, 2014.
ADDRESSES: Submit electronic
comments 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. All
comments should be identified with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Elizabeth Giaquinto, Center for Drug
Evaluation and Research (HFD–600),
Food and Drug Administration, 7519
SUMMARY:
E:\FR\FM\23JAN1.SGM
23JAN1
Federal Register / Vol. 79, No. 15 / Thursday, January 23, 2014 / Notices
Standish Pl., Rockville, MD 20885, 240–
276–8607, elizabeth.giaquinto@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
sroberts on DSK5SPTVN1PROD with NOTICES
I. Background
On July 9, 2012, the President signed
the Generic Drug User Fee Amendments
(GDUFA) (Pub. L. 112–144, Title III)
into law. With the enactment of
GDUFA, OGD committed to expedite
the availability of high-quality, lower
cost generic drugs by bringing greater
predictability to the review times for
ANDAs and associated amendments and
supplements. OGD agreed to specific
performance review metrics to reduce
the time needed to bring a generic drug
to market compared to typical preGDUFA review times. However, OGD’s
review is often hindered by the quality
of the ANDA submissions.
As part of efforts to fulfill its GDUFA
commitments, OGD is soliciting input
and suggestions from all interested
stakeholders on how to improve the
completeness and quality of ANDA
submissions to OGD. FDA is interested
in hearing about any difficulties
sponsors are having developing and
preparing their applications for
submission that FDA could help address
(please see specific questions for
comment listed in this section of the
document). FDA is also seeking input
on how to best share suggestions for
improving the quality of ANDA
submissions with industry. To receive
comments and suggestions from the
public, FDA is establishing a public
docket. Improving the quality of ANDA
submissions will result in more
submissions accepted for filing, fewer
amendments, and easily correctable
deficiencies, and ultimately, more
generic drug approvals.
FDA review staff routinely note
common, recurring deficiencies found
in ANDA submissions to OGD and try
to communicate these deficiencies to
industry in guidance documents and
during presentations. Common,
recurring deficiencies include, but are
not limited to:
• Filing: Failure to provide a
completed Form FDA 356h; unjustified
inactive ingredient levels; inadequate
dissolution data; packaging less than the
recommended threshold amount
without justification; inadequate or
insufficient stability data; submissions
of non-qualitative and non-quantitative
(not Q/Q) same formulations; electronic
submission and formatting deficiencies;
applications containing an incorrect or
unfounded basis of submission.
• Chemistry: Poor or inadequate
justification of impurities limits; failure
VerDate Mar<15>2010
21:50 Jan 22, 2014
Jkt 232001
to provide a list of potential impurities
and their origins; failure to provide
adequate verification of analytical
procedures for active pharmaceutical
ingredient and finished dosage forms,
where appropriate; failure to identify
the critical manufacturing process
parameters or to link in-process controls
to development studies; failure to
provide appropriate acceptance criteria
of manufacturing yields for the critical
steps, or providing yield values varying
without adequate rationale or
explanation.
• Sterility assurance for sterile drug
product applications manufactured by
aseptic processing: Failure to describe
sterilization and/or depyrogenation of
relevant equipment and components
that may come in contact with the
sterile drug; failure to provide relevant
validation data for sterilization and/or
depyrogenation of relevant equipment
and components that may come in
contact with the sterile drug; failure to
provide validation data for sterilizing
grade filters, if needed; failure to
provide process simulation data for the
proposed aseptic filling process/line/
room.
• Bioequivalence: Inaccurate and/or
incomplete information contained in
electronic tables; submission of
pharmacokinetic repeats; inaccurate
and/or incomplete biowaiver requests
(e.g., inappropriate method of solubility
determination, lack of dissolution data
for all strengths, missing standard
operating procedures for analytical
methods).
• Fatal flaws: Significant flaws in the
design of a drug product such that the
proposed product will not be able to
meet all conditions of use of the
reference listed drug.
• Drug master files: Submission
contains more than a single drug
substance or more than a single drug
manufacturing process; failure to update
the drug master file following a large
number of amendments or time lapse
since the original submission; failure to
provide a complete description of
manufacturing process and controls;
failure to justify appropriate starting
materials.
As noted previously, this list provides
examples of common, recurring
deficiencies FDA has identified. FDA is
particularly interested to learn what
steps it can take to help reduce these
deficiencies and enhance the
completeness and quality of ANDA
submissions. Comments submitted to
this docket are encouraged to address
one or more of the following points, as
well as any others that the commenter
thinks are important:
PO 00000
Frm 00055
Fmt 4703
Sfmt 4703
3829
1. What aspects of the ANDA
application process are confusing or not
well defined?
2. What problems do ANDA
applicants encounter when developing a
submission that FDA could help
address?
3. Prior to GDUFA, were ANDA
submissions consistently slowed or
stalled at certain recurring review points
post-filing? If so, why?
4. How should FDA share suggestions
for improving ANDA submissions with
industry, beyond issuing regulatory
guidance?
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.
Dated: January 16, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–01309 Filed 1–22–14; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–0001]
Society of Clinical Research
Associates—Food and Drug
Administration: Food and Drug
Administration Clinical Trial
Requirements, Regulations,
Compliance, and Good Clinical
Practice; Public Workshop
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of public workshop.
The Food and Drug Administration
(FDA) is announcing an educational
conference co-sponsored with the
Society of Clinical Research Associates
(SoCRA). The public workshop
regarding FDA’s clinical trial
requirements is designed to aid the
clinical research professional’s
understanding of the mission,
responsibilities, and authority of FDA,
and to facilitate interaction with FDA
representatives. The program will focus
on the relationships among FDA and
E:\FR\FM\23JAN1.SGM
23JAN1
]]>Agencies
[Federal Register Volume 79, Number 15 (Thursday, January 23, 2014)]
[Notices]
[Pages 3828-3829]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-01309]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-0032]
Improving the Quality of Abbreviated New Drug Application
Submissions to the Food and Drug Administration; Establishment of a
Public Docket
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; establishment of docket; request for comments.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is establishing a
public docket to receive input and suggestions from the public on ways
to improve the quality of abbreviated new drug applications (ANDAs) and
associated amendments and supplements to FDA's Office of Generic Drugs
(OGD). Specifically, FDA is interested in hearing about any
difficulties sponsors are having developing and preparing their ANDA
submissions that FDA could help address, for example by providing more
or better information to industry. This action is intended to solicit
suggestions that will improve the completeness and quality of ANDA
submissions to FDA. FDA is also seeking input on how to best share
suggestions for improving the quality of ANDAs with the generic drug
industry. More complete, higher quality ANDA submissions will
positively affect the availability of low-cost, high-quality generic
drugs to the public.
DATES: Although FDA welcomes comments at any time, to help FDA address
issues related to ANDA submission quality in a timely fashion, we
encourage submission of electronic or written comments by March 24,
2014.
ADDRESSES: Submit electronic comments 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. All comments should be identified with the docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Elizabeth Giaquinto, Center for Drug
Evaluation and Research (HFD-600), Food and Drug Administration, 7519
[[Page 3829]]
Standish Pl., Rockville, MD 20885, 240-276-8607,
elizabeth.giaquinto@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
On July 9, 2012, the President signed the Generic Drug User Fee
Amendments (GDUFA) (Pub. L. 112-144, Title III) into law. With the
enactment of GDUFA, OGD committed to expedite the availability of high-
quality, lower cost generic drugs by bringing greater predictability to
the review times for ANDAs and associated amendments and supplements.
OGD agreed to specific performance review metrics to reduce the time
needed to bring a generic drug to market compared to typical pre-GDUFA
review times. However, OGD's review is often hindered by the quality of
the ANDA submissions.
As part of efforts to fulfill its GDUFA commitments, OGD is
soliciting input and suggestions from all interested stakeholders on
how to improve the completeness and quality of ANDA submissions to OGD.
FDA is interested in hearing about any difficulties sponsors are having
developing and preparing their applications for submission that FDA
could help address (please see specific questions for comment listed in
this section of the document). FDA is also seeking input on how to best
share suggestions for improving the quality of ANDA submissions with
industry. To receive comments and suggestions from the public, FDA is
establishing a public docket. Improving the quality of ANDA submissions
will result in more submissions accepted for filing, fewer amendments,
and easily correctable deficiencies, and ultimately, more generic drug
approvals.
FDA review staff routinely note common, recurring deficiencies
found in ANDA submissions to OGD and try to communicate these
deficiencies to industry in guidance documents and during
presentations. Common, recurring deficiencies include, but are not
limited to:
Filing: Failure to provide a completed Form FDA 356h;
unjustified inactive ingredient levels; inadequate dissolution data;
packaging less than the recommended threshold amount without
justification; inadequate or insufficient stability data; submissions
of non-qualitative and non-quantitative (not Q/Q) same formulations;
electronic submission and formatting deficiencies; applications
containing an incorrect or unfounded basis of submission.
Chemistry: Poor or inadequate justification of impurities
limits; failure to provide a list of potential impurities and their
origins; failure to provide adequate verification of analytical
procedures for active pharmaceutical ingredient and finished dosage
forms, where appropriate; failure to identify the critical
manufacturing process parameters or to link in-process controls to
development studies; failure to provide appropriate acceptance criteria
of manufacturing yields for the critical steps, or providing yield
values varying without adequate rationale or explanation.
Sterility assurance for sterile drug product applications
manufactured by aseptic processing: Failure to describe sterilization
and/or depyrogenation of relevant equipment and components that may
come in contact with the sterile drug; failure to provide relevant
validation data for sterilization and/or depyrogenation of relevant
equipment and components that may come in contact with the sterile
drug; failure to provide validation data for sterilizing grade filters,
if needed; failure to provide process simulation data for the proposed
aseptic filling process/line/room.
Bioequivalence: Inaccurate and/or incomplete information
contained in electronic tables; submission of pharmacokinetic repeats;
inaccurate and/or incomplete biowaiver requests (e.g., inappropriate
method of solubility determination, lack of dissolution data for all
strengths, missing standard operating procedures for analytical
methods).
Fatal flaws: Significant flaws in the design of a drug
product such that the proposed product will not be able to meet all
conditions of use of the reference listed drug.
Drug master files: Submission contains more than a single
drug substance or more than a single drug manufacturing process;
failure to update the drug master file following a large number of
amendments or time lapse since the original submission; failure to
provide a complete description of manufacturing process and controls;
failure to justify appropriate starting materials.
As noted previously, this list provides examples of common,
recurring deficiencies FDA has identified. FDA is particularly
interested to learn what steps it can take to help reduce these
deficiencies and enhance the completeness and quality of ANDA
submissions. Comments submitted to this docket are encouraged to
address one or more of the following points, as well as any others that
the commenter thinks are important:
1. What aspects of the ANDA application process are confusing or
not well defined?
2. What problems do ANDA applicants encounter when developing a
submission that FDA could help address?
3. Prior to GDUFA, were ANDA submissions consistently slowed or
stalled at certain recurring review points post-filing? If so, why?
4. How should FDA share suggestions for improving ANDA submissions
with industry, beyond issuing regulatory guidance?
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.
Dated: January 16, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-01309 Filed 1-22-14; 8:45 am]
BILLING CODE 4160-01-P
