New Insights for Product Development and Bioequivalence Assessments of Generic Orally Inhaled and Nasal Drug Products; Public Workshop; Request for Comments, 60201-60203 [2017-27279]
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Federal Register / Vol. 82, No. 242 / Tuesday, December 19, 2017 / Notices
comments and suggestions submitted
within 60 days of this publication.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2017–27306 Filed 12–18–17; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–6716]
New Insights for Product Development
and Bioequivalence Assessments of
Generic Orally Inhaled and Nasal Drug
Products; Public Workshop; Request
for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice of public workshop;
request for comments.
ACTION:
The Food and Drug
Administration (FDA, the Agency, or
we) is announcing the following public
workshop entitled ‘‘New Insights for
Product Development and
Bioequivalence Assessments of Generic
Orally Inhaled and Nasal Drug
Products.’’ The purposes of the
workshop are to present the outcomes
from the research projects conducted
under the Generic Drug User Fee
Amendments (GDUFA) Regulatory
Science Research Program; discuss how
regulatory science initiatives have
helped address regulatory science
knowledge gaps by providing insights
on factors that influence the
performance of generic orally inhaled
and nasal drug products (OINDPs);
share the Agency’s experience on the
utility of novel analytical tools and
methods developed under the regulatory
science initiative for generic OINDP
product development and
bioequivalence assessments; and obtain
input from the public on what, when,
where, and how analytical methods and
procedures should be applied in the
development and review of abbreviated
new drug applications (ANDAs) for
complex OINDPs.
DATES: The public workshop will be
held on January 9, 2018, from 8:30 a.m.
to 4:30 p.m. Individuals who wish to
attend the workshop must register by
December 30, 2017. Submit either
electronic or written comments on this
public workshop by February 14, 2018.
See the SUPPLEMENTARY INFORMATION
section for registration date and
information.
ADDRESSES: The public workshop will
be held at FDA White Oak Campus,
sradovich on DSK3GMQ082PROD with NOTICES
SUMMARY:
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10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (Rm.
1503 B+C), Silver Spring, MD 20993–
0002. Entrance for the public workshop
participants (non-FDA employees) is
through Building 1, where routine
security check procedures will be
performed. For parking and security
information, please refer to https://
www.fda.gov/AboutFDA/
WorkingatFDA/BuildingsandFacilities/
WhiteOakCampusInformation/
ucm241740.htm.
You may submit comments as
follows. Please note that late, untimely
filed comments will not be considered.
Electronic comments must be submitted
on or before February 14, 2018. The
https://www.regulations.gov electronic
filing system will accept comments
until midnight Eastern Time at the end
of February 14, 2018. Comments
received by mail/hand delivery/courier
(for written/paper submissions) will be
considered timely if they are
postmarked or the delivery service
acceptance receipt is on or before that
date.
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
PO 00000
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• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2017–N–6716 for ‘‘New Insights for
Product Development and
Bioequivalence Assessments of Generic
Orally Inhaled and Nasal Drug
Products.’’ Received comments, those
filed in a timely manner (see
ADDRESSES), will be placed in the docket
and, except for those submitted as
‘‘Confidential Submissions,’’ publicly
viewable at https://www.regulations.gov
or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday
through Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
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Federal Register / Vol. 82, No. 242 / Tuesday, December 19, 2017 / Notices
FOR FURTHER INFORMATION CONTACT:
Renishkumar Delvadia, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 4704,
Silver Spring, MD 20993, 240–402–
7979, email: Renishkumar.delvadia@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
sradovich on DSK3GMQ082PROD with NOTICES
I. Background
In the Regulatory Science
Enhancements section of the GDUFA
Reauthorization Performance Goals and
Program Enhancement Fiscal Years
2018–2022 (GDUFA II Commitment
Letter) (available at: https://
www.fda.gov/downloads/ForIndustry/
UserFees/GenericDrugUserFees/
UCM525234.pdf) FDA committed to
‘‘conduct internal and external research
to support fulfilment of submission
review and pre-ANDA commitments.’’
This continues commitments made in
the GDUFA Program Performance Goals
and Procedures for fiscal years 2013
through 2017 (GDUFA I Commitment
Letter) (available at: https://
www.fda.gov/downloads/ForIndustry/
UserFees/GenericDrugUserFees/
UCM282505.pdf). For complex OINDPs,
this research is intended to support the
development of scientific guidance and
Agency policy to clarify the ANDA
pathway for OINDPs and aid our
understanding about the critical product
attributes relevant for in vivo
performance of OINDPs. This work has
led to the development of tools
beneficial to both industry and FDA for
developing and evaluating generic
OINDPs. This regulatory science
research includes, but is not limited to,
the following: (1) Identification of
critical formulation and device
attributes of generic OINDPs; (2)
development of clinically relevant in
vitro tools for prediction of in vivo
regional drug deposition and
dissolution from OINDPs; (3)
development of computational fluid
dynamic (CFD) and physiologicallybased pharmacokinetic (PBPK) models
for prediction of the local and systemic
exposure of drugs delivered through
OINDPs and to assess their applicability
in generic OINDP development
programs; and (4) identification,
validation, and standardization of novel
techniques that can be used for future
bioequivalence assessments for generic
OINDPs.
Since its commencement in 2012, the
GDUFA Regulatory Science Research
Program has continuously aided our
understanding about the critical product
attributes that are relevant for in vivo
performance of OINDPs, and has led to
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the development of tools beneficial to
both industry and FDA for developing
and assessing generic OINDPs. Several
external and internal research projects
have been initiated under the GDUFA
Regulatory Science Research Program.
The outcomes from these research
studies have provided valuable insight
about the factors influencing the
performance of OINDPs and have
helped the Agency fill regulatory
science gaps in this area. For instance,
advanced modeling tools developed
under this initiative, such as CFD and
PBPK, can provide insights about
patient-device interactions and
information about both local and
systemic bioavailability, which can
better characterize critical device and
formulation attributes to further our
understanding of generic drug-device
combination products. Clinically
relevant mouth-throat and nasal models
are another example of this research
which have shown good in vivo
correlations in predicting regional drug
deposition; these physical models allow
us to predict the impact of certain
performance characteristics of OINDPs
on regional drug deposition in a realistic
manner, potentially without the need
for conducting comparative clinical
endpoint studies. Similarly,
Morphologically Directed Raman
Spectroscopy (MDRS), a novel particle
sizing method explored under the
initiative, has shown promise in
differentiating nasal suspension
formulations of different drug particle
sizes, and has opened the possibility of
a new regulatory pathway for the
approval of generic nasal suspension
products without the need to conduct a
comparative clinical endpoint study.
Another research outcome developed
under the science initiative for OINDPs
has been work involving in-vitro
dissolution methods, which are
providing insights on the bridge
between local drug deposition and its
downstream systemic bioavailability.
Our enhanced understanding about
OINDPs from these regulatory sciencebased initiatives have informed us
during the development of productspecific guidances for OINDPs, resulting
in the publication of more than 39
product-specific guidance documents
since the implementation of GDUFA in
2012.
To enhance communication of recent
advances, including those supported by
GDUFA funds, FDA plans to hold a
public workshop on new analytical
methods and assessment criteria for
characterization of OINDPs.
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II. Purpose and Scope of the Workshop
The purposes of the workshop are as
follows:
1. To present the outcomes from the
research projects initiated under the
GDUFA Regulatory Science Research
Program;
2. To discuss how regulatory science
initiatives have helped address
regulatory science gaps by providing
insight on factors that influence the
performance of OINDPs;
3. To share the Agency’s experience
on the utility of novel analytical tools
and methods developed under the
regulatory science initiative for OINDP
product development and
bioequivalence assessments; and
4. To obtain input from the public on
what, when, where, and how analytical
methods and procedures should be
applied in the development and review
of complex OINDP ANDAs for
therapeutic equivalence.
The scope of the workshop covers the
current status of methods for
characterization and bioequivalence
evaluation of generic OINDPs.
The focus of this public workshop is
on the evaluation of these new methods
for characterizing and demonstrating
therapeutic equivalence of OINDPs,
including discussing the areas in which
these methods may significantly
contribute to generic product
development and regulatory
understanding, how and under what
conditions the methods should be
conducted and evaluated, and inherent
scientific challenges with this complex
class of products.
Public input will improve FDA’s
current understanding of present and
future methods available for evaluating
OINDP therapeutic equivalence. The
knowledge gained through this
workshop discussion will be
summarized and disseminated to the
scientific community by publication(s).
III. Scope of Public Input Requested
FDA seeks input from the public on
when, where, and how to utilize new
methods for development of generic
OINDPs and in the regulatory review of
bioequivalence. Specific topics to be
addressed include:
1. Identifying the areas in which new
in vitro and computational methods can
contribute to the development of generic
OINDPs;
2. Discussing how in vitro testing for
demonstrating OINDP therapeutic
equivalence should be conducted and
evaluated; and
3. Addressing the scientific challenges
in assessing critical quality attributes of
OINDPs and in developing new
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Federal Register / Vol. 82, No. 242 / Tuesday, December 19, 2017 / Notices
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methods for demonstrating OINDP
therapeutic equivalence.
Registration: Persons interested in
attending this public workshop must
register online by December 30, 2017, by
going to https://www.fda.gov/Drugs/
NewsEvents/ucm576064.htm. Please
provide complete contact information
for each attendee, including name, title,
affiliation, address, email, and
telephone. The workshop agenda and
other background materials will be
available approximately 2 weeks before
the workshop at https://www.fda.gov/
Drugs/NewsEvents/ucm576064.htm.
The agenda will include time for
questions and answers throughout the
day and for general comments and
questions from the audience following
panel discussions.
Registration is free and based on
space availability, with priority given to
early registrants. Persons interested in
attending this public workshop must
register by December 30, 2017, midnight
Eastern Time. Early registration is
recommended because seating is
limited; therefore, FDA may limit the
number of participants from each
organization. If time and space permit,
onsite registration on the day of the
public workshop will be provided
beginning at 8:30 a.m.
If you need special accommodations
due to a disability, please contact
Renishkumar Delvadia no later than
December 30, 2017.
Streaming Webcast of the public
workshop: This public workshop will
also be webcast. A live webcast of this
workshop will be viewable at https://
collaboration.fda.gov/r19djs3yfsf/ on
the day of the workshop. A video record
of the workshop will be available at the
same web address for 1 year. If you have
never attended a Connect Pro event
before, test your connection at https://
collaboration.fda.gov/common/help/en/
support/meeting_test.htm. To get a
quick overview of the Connect Pro
program, visit https://www.adobe.com/
go/connectpro_overview. FDA has
verified the website addresses in this
document, as of the date this document
publishes in the Federal Register, but
websites are subject to change over time.
Dated: December 13, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–27279 Filed 12–18–17; 8:45 am]
BILLING CODE 4164–01–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0075]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Good Laboratory
Practice Regulations for Nonclinical
Studies
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by January 18,
2018.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, Fax: 202–
395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0119. Also
include the FDA docket number found
in brackets in the heading of this
document.
SUMMARY:
Ila
S. Mizrachi, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–7726, PRAStaff@
fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
Good Laboratory Practice Regulations
for Nonclinical Studies—21 CFR Part
58
OMB Control Number 0910–0119—
Extension
Sections 409, 505, 512, and 515 of the
Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 348, 355, 360b, and 360e) and
related statutes require manufacturers of
food additives, human drugs and
biological products, animal drugs, and
medical devices to demonstrate the
safety and utility of their product by
submitting applications to FDA for
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60203
research or marketing permits. Such
applications contain, among other
important items, full reports of all
studies done to demonstrate product
safety in man and/or other animals. In
order to ensure adequate quality control
for these studies and to provide an
adequate degree of consumer protection,
the Agency issued good laboratory
practice (GLP) regulations for
nonclinical laboratory studies in part 58
(21 CFR part 58). The regulations
specify minimum standards for the
proper conduct of safety testing and
contain sections on facilities, personnel,
equipment, standard operating
procedures (SOPs), test and control
articles, quality assurance, protocol and
conduct of a safety study, records and
reports, and laboratory disqualification.
Part 58 requires testing facilities
engaged in conducting toxicological
studies to retain, and make available to
regulatory officials, records regarding
compliance with GLPs. Records are
maintained on file at each testing
facility and examined there periodically
by FDA inspectors. The GLP regulations
require that, for each nonclinical
laboratory study, a final report be
prepared that documents the results of
quality assurance unit inspections, test
and control article characterization,
testing of mixtures of test and control
articles with carriers, and an overall
interpretation of nonclinical laboratory
studies. The GLP regulations also
require written records pertaining to: (1)
Personnel job descriptions and
summaries of training and experience;
(2) master schedules, protocols and
amendments thereto, inspection reports,
and SOPs; (3) equipment inspection,
maintenance, calibration, and testing
records; (4) documentation of feed and
water analyses, and animal treatments;
(5) test article accountability records;
and (6) study documentation and raw
data.
Recordkeeping is necessary to
document the conduct of nonclinical
laboratory studies of FDA-regulated
products to ensure the quality and
integrity of the resulting final study
report on which a regulatory decision
may be based. Written SOPs and records
of actions taken are essential for testing
facilities to implement GLPs effectively.
Further, they are essential for FDA to be
able to determine a testing facility’s
compliance with the GLP regulations in
part 58.
In a notice of proposed rulemaking
published in the Federal Register of
August 24, 2016 (81 FR 58342), we
proposed changes in our GLP
regulations, including some of those
listed in tables 1 and 2 of this
document. The document included
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]]>Agencies
[Federal Register Volume 82, Number 242 (Tuesday, December 19, 2017)]
[Notices]
[Pages 60201-60203]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-27279]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-N-6716]
New Insights for Product Development and Bioequivalence
Assessments of Generic Orally Inhaled and Nasal Drug Products; Public
Workshop; Request for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop; request for comments.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
announcing the following public workshop entitled ``New Insights for
Product Development and Bioequivalence Assessments of Generic Orally
Inhaled and Nasal Drug Products.'' The purposes of the workshop are to
present the outcomes from the research projects conducted under the
Generic Drug User Fee Amendments (GDUFA) Regulatory Science Research
Program; discuss how regulatory science initiatives have helped address
regulatory science knowledge gaps by providing insights on factors that
influence the performance of generic orally inhaled and nasal drug
products (OINDPs); share the Agency's experience on the utility of
novel analytical tools and methods developed under the regulatory
science initiative for generic OINDP product development and
bioequivalence assessments; and obtain input from the public on what,
when, where, and how analytical methods and procedures should be
applied in the development and review of abbreviated new drug
applications (ANDAs) for complex OINDPs.
DATES: The public workshop will be held on January 9, 2018, from 8:30
a.m. to 4:30 p.m. Individuals who wish to attend the workshop must
register by December 30, 2017. Submit either electronic or written
comments on this public workshop by February 14, 2018. See the
SUPPLEMENTARY INFORMATION section for registration date and
information.
ADDRESSES: The public workshop will be held at FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room
(Rm. 1503 B+C), Silver Spring, MD 20993-0002. Entrance for the public
workshop participants (non-FDA employees) is through Building 1, where
routine security check procedures will be performed. For parking and
security information, please refer to https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
You may submit comments as follows. Please note that late, untimely
filed comments will not be considered. Electronic comments must be
submitted on or before February 14, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of February 14, 2018. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2017-N-6716 for ``New Insights for Product Development and
Bioequivalence Assessments of Generic Orally Inhaled and Nasal Drug
Products.'' Received comments, those filed in a timely manner (see
ADDRESSES), will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
[[Page 60202]]
FOR FURTHER INFORMATION CONTACT: Renishkumar Delvadia, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 4704, Silver Spring, MD 20993, 240-402-
7979, email: [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
In the Regulatory Science Enhancements section of the GDUFA
Reauthorization Performance Goals and Program Enhancement Fiscal Years
2018-2022 (GDUFA II Commitment Letter) (available at: https://www.fda.gov/downloads/ForIndustry/UserFees/GenericDrugUserFees/UCM525234.pdf) FDA committed to ``conduct internal and external
research to support fulfilment of submission review and pre-ANDA
commitments.'' This continues commitments made in the GDUFA Program
Performance Goals and Procedures for fiscal years 2013 through 2017
(GDUFA I Commitment Letter) (available at: https://www.fda.gov/downloads/ForIndustry/UserFees/GenericDrugUserFees/UCM282505.pdf). For
complex OINDPs, this research is intended to support the development of
scientific guidance and Agency policy to clarify the ANDA pathway for
OINDPs and aid our understanding about the critical product attributes
relevant for in vivo performance of OINDPs. This work has led to the
development of tools beneficial to both industry and FDA for developing
and evaluating generic OINDPs. This regulatory science research
includes, but is not limited to, the following: (1) Identification of
critical formulation and device attributes of generic OINDPs; (2)
development of clinically relevant in vitro tools for prediction of in
vivo regional drug deposition and dissolution from OINDPs; (3)
development of computational fluid dynamic (CFD) and physiologically-
based pharmacokinetic (PBPK) models for prediction of the local and
systemic exposure of drugs delivered through OINDPs and to assess their
applicability in generic OINDP development programs; and (4)
identification, validation, and standardization of novel techniques
that can be used for future bioequivalence assessments for generic
OINDPs.
Since its commencement in 2012, the GDUFA Regulatory Science
Research Program has continuously aided our understanding about the
critical product attributes that are relevant for in vivo performance
of OINDPs, and has led to the development of tools beneficial to both
industry and FDA for developing and assessing generic OINDPs. Several
external and internal research projects have been initiated under the
GDUFA Regulatory Science Research Program. The outcomes from these
research studies have provided valuable insight about the factors
influencing the performance of OINDPs and have helped the Agency fill
regulatory science gaps in this area. For instance, advanced modeling
tools developed under this initiative, such as CFD and PBPK, can
provide insights about patient-device interactions and information
about both local and systemic bioavailability, which can better
characterize critical device and formulation attributes to further our
understanding of generic drug-device combination products. Clinically
relevant mouth-throat and nasal models are another example of this
research which have shown good in vivo correlations in predicting
regional drug deposition; these physical models allow us to predict the
impact of certain performance characteristics of OINDPs on regional
drug deposition in a realistic manner, potentially without the need for
conducting comparative clinical endpoint studies. Similarly,
Morphologically Directed Raman Spectroscopy (MDRS), a novel particle
sizing method explored under the initiative, has shown promise in
differentiating nasal suspension formulations of different drug
particle sizes, and has opened the possibility of a new regulatory
pathway for the approval of generic nasal suspension products without
the need to conduct a comparative clinical endpoint study. Another
research outcome developed under the science initiative for OINDPs has
been work involving in-vitro dissolution methods, which are providing
insights on the bridge between local drug deposition and its downstream
systemic bioavailability. Our enhanced understanding about OINDPs from
these regulatory science-based initiatives have informed us during the
development of product-specific guidances for OINDPs, resulting in the
publication of more than 39 product-specific guidance documents since
the implementation of GDUFA in 2012.
To enhance communication of recent advances, including those
supported by GDUFA funds, FDA plans to hold a public workshop on new
analytical methods and assessment criteria for characterization of
OINDPs.
II. Purpose and Scope of the Workshop
The purposes of the workshop are as follows:
1. To present the outcomes from the research projects initiated
under the GDUFA Regulatory Science Research Program;
2. To discuss how regulatory science initiatives have helped
address regulatory science gaps by providing insight on factors that
influence the performance of OINDPs;
3. To share the Agency's experience on the utility of novel
analytical tools and methods developed under the regulatory science
initiative for OINDP product development and bioequivalence
assessments; and
4. To obtain input from the public on what, when, where, and how
analytical methods and procedures should be applied in the development
and review of complex OINDP ANDAs for therapeutic equivalence.
The scope of the workshop covers the current status of methods for
characterization and bioequivalence evaluation of generic OINDPs.
The focus of this public workshop is on the evaluation of these new
methods for characterizing and demonstrating therapeutic equivalence of
OINDPs, including discussing the areas in which these methods may
significantly contribute to generic product development and regulatory
understanding, how and under what conditions the methods should be
conducted and evaluated, and inherent scientific challenges with this
complex class of products.
Public input will improve FDA's current understanding of present
and future methods available for evaluating OINDP therapeutic
equivalence. The knowledge gained through this workshop discussion will
be summarized and disseminated to the scientific community by
publication(s).
III. Scope of Public Input Requested
FDA seeks input from the public on when, where, and how to utilize
new methods for development of generic OINDPs and in the regulatory
review of bioequivalence. Specific topics to be addressed include:
1. Identifying the areas in which new in vitro and computational
methods can contribute to the development of generic OINDPs;
2. Discussing how in vitro testing for demonstrating OINDP
therapeutic equivalence should be conducted and evaluated; and
3. Addressing the scientific challenges in assessing critical
quality attributes of OINDPs and in developing new
[[Page 60203]]
methods for demonstrating OINDP therapeutic equivalence.
Registration: Persons interested in attending this public workshop
must register online by December 30, 2017, by going to https://www.fda.gov/Drugs/NewsEvents/ucm576064.htm. Please provide complete
contact information for each attendee, including name, title,
affiliation, address, email, and telephone. The workshop agenda and
other background materials will be available approximately 2 weeks
before the workshop at https://www.fda.gov/Drugs/NewsEvents/ucm576064.htm. The agenda will include time for questions and answers
throughout the day and for general comments and questions from the
audience following panel discussions.
Registration is free and based on space availability, with priority
given to early registrants. Persons interested in attending this public
workshop must register by December 30, 2017, midnight Eastern Time.
Early registration is recommended because seating is limited;
therefore, FDA may limit the number of participants from each
organization. If time and space permit, onsite registration on the day
of the public workshop will be provided beginning at 8:30 a.m.
If you need special accommodations due to a disability, please
contact Renishkumar Delvadia no later than December 30, 2017.
Streaming Webcast of the public workshop: This public workshop will
also be webcast. A live webcast of this workshop will be viewable at
https://collaboration.fda.gov/r19djs3yfsf/ on the day of the workshop.
A video record of the workshop will be available at the same web
address for 1 year. If you have never attended a Connect Pro event
before, test your connection at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. To get a quick overview of the
Connect Pro program, visit https://www.adobe.com/go/connectpro_overview. FDA has verified the website addresses in this
document, as of the date this document publishes in the Federal
Register, but websites are subject to change over time.
Dated: December 13, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-27279 Filed 12-18-17; 8:45 am]
BILLING CODE 4164-01-P
