Notice2023-12206
Demonstrating Bioequivalence for Type A Medicated Articles Containing Active Pharmaceutical Ingredient(s) Considered To Be Poorly Soluble in Aqueous Media, That Exhibit Little to No Systemic Bioavailability, and Are Locally Acting; Draft Guidance for Industry; Availability
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Published
June 8, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry (GFI) #279 entitled "Demonstrating Bioequivalence for Type A Medicated Articles Containing Active Pharmaceutical Ingredient(s) Considered To Be Poorly Soluble in Aqueous Media, That Exhibit Little to No Systemic Bioavailability, and Are Locally Acting; Draft Guidance for Industry." This draft guidance describes an approach to satisfy the requirements for the completion of the Bioequivalence technical section for generic Type A medicated articles (TAMAs) containing poorly soluble, locally acting, active pharmaceutical ingredients (APIs) that have little to no systemic absorption, and for which blood level studies are not considered appropriate to demonstrate product bioequivalence. The suggested approach described in this draft guidance uses a combination of in vitro and in vivo data to support a determination of bioequivalence to address the unique challenges associated with demonstrating bioequivalence of TAMAs containing poorly soluble, locally acting APIs that have little to no systemic absorption.
Full Text
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<title>Federal Register, Volume 88 Issue 110 (Thursday, June 8, 2023)</title>
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[Federal Register Volume 88, Number 110 (Thursday, June 8, 2023)]
[Notices]
[Pages 37551-37552]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-12206]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-D-1275]
Demonstrating Bioequivalence for Type A Medicated Articles
Containing Active Pharmaceutical Ingredient(s) Considered To Be Poorly
Soluble in Aqueous Media, That Exhibit Little to No Systemic
Bioavailability, and Are Locally Acting; Draft Guidance for Industry;
Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry (GFI) #279 entitled
``Demonstrating Bioequivalence for Type A Medicated Articles Containing
Active Pharmaceutical Ingredient(s) Considered To Be Poorly Soluble in
Aqueous Media, That Exhibit Little to No Systemic Bioavailability, and
Are Locally Acting; Draft Guidance for Industry.'' This draft guidance
describes an approach to satisfy the requirements for the completion of
the Bioequivalence technical section for generic Type A medicated
articles (TAMAs) containing poorly soluble, locally acting, active
pharmaceutical ingredients (APIs) that have little to no systemic
absorption, and for which blood level studies are not considered
appropriate to demonstrate product bioequivalence. The suggested
approach described in this draft guidance uses a combination of in
vitro and in vivo data to support a determination of bioequivalence to
address the unique challenges associated with demonstrating
bioequivalence of TAMAs containing poorly soluble, locally acting APIs
that have little to no systemic absorption.
DATES: Submit either electronic or written comments on the draft
guidance by August 7, 2023 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.
ADDRESSES: You may submit comments on any guidance at any time as
follows:
Electronic Submissions
Submit electronic comments in the following way:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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-2023-D-1275 for ``Demonstrating Bioequivalence for Type A Medicated
Articles Containing Active Pharmaceutical Ingredient(s) Considered To
Be Poorly Soluble in Aqueous Media, That Exhibit Little to No Systemic
Bioavailability, and Are Locally Acting.'' Received comments will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday, 240-402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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, 240-402-7500.
You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single copies of the guidance to the
Policy and Regulations Staff (HFV-6), Center for Veterinary Medicine,
Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855.
Send one self-addressed adhesive label to assist that office in
processing your requests. See the SUPPLEMENTARY INFORMATION section for
electronic access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT: Ian Hendricks, Center for Veterinary
Medicine (HFV-172), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240-402-0853, <a href="/cdn-cgi/l/email-protection#88c1e9e6a6c0ede6ecfae1ebe3fbc8eeece9a6e0e0fba6efe7fe"><span class="__cf_email__" data-cfemail="672e0609492f020903150e040c1427010306490f0f1449000811">[email protected]</span></a>.
[[Page 37552]]
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
#279 entitled ``Demonstrating Bioequivalence for Type A Medicated
Articles Containing Active Pharmaceutical Ingredient(s) Considered To
Be Poorly Soluble in Aqueous Media, That Exhibit Little to No Systemic
Bioavailability, and Are Locally Acting.'' Section 512(c)(2)(A)(vi) of
the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C.
360b(c)(2)(A)(vi)) requires that generic new animal drug products be
shown to be bioequivalent to the reference listed new animal drug
(RLNAD), and section 512(n)(1)(E) of the FD&C Act requires that the
sponsor provide information to show that the proposed product is
bioequivalent to the RLNAD.
FDA's Center for Veterinary Medicine (CVM) has issued guidance on
demonstrating bioequivalence through in vivo studies, and guidance on
product types that may be eligible for a waiver from the requirement to
perform in vivo bioequivalence studies, including oral solutions and
other solubilized forms, parenteral solutions, some topically applied
dosage forms (see Guidance for Industry #35, ``Bioequivalence
Guidance'') and TAMAs with APIs that are considered to be water soluble
(see Guidance for Industry #171, ``Demonstrating Bioequivalence for
Soluble Powder Oral Dosage Form Products, and Type A Medicated Articles
Manufactured from Active Pharmaceutical Ingredients Considered To Be
Soluble in Aqueous Media''). However, these guidance documents do not
specifically address the unique challenges associated with
demonstrating bioequivalence of TAMAs containing poorly soluble,
locally acting APIs. Therefore, this guidance is intended to address
these unique challenges. In particular, when the TAMA is not a
candidate for a waiver from the requirement to conduct in vivo blood
level bioequivalence studies, CVM recommends via this guidance that
product bioequivalence be demonstrated using alternative test
approaches to those relying exclusively on animal testing. This draft
guidance, when finalized, is intended to address these situations.
This level 1 draft guidance is being issued consistent with FDA's
good guidance practices regulation (21 CFR 10.115). The draft guidance,
when finalized, will represent the current thinking of FDA on
``Demonstrating Bioequivalence for Type A Medicated Articles Containing
Active Pharmaceutical Ingredient(s) Considered To Be Poorly Soluble in
Aqueous Media, That Exhibit Little to No Systemic Bioavailability, and
Are Locally Acting.'' It does not establish any rights for any person
and is not binding on FDA or the public. You can use an alternative
approach if it satisfies the requirements of the applicable statutes
and regulations.
II. Paperwork Reduction Act of 1995
While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information in section 512(n)(1) of the FD&C Act have been approved
under OMB control number 0910-0669.
III. Electronic Access
Persons with access to the internet may obtain the draft guidance
at <a href="https://www.fda.gov/animal-veterinary/guidance-regulations/guidance-industry">https://www.fda.gov/animal-veterinary/guidance-regulations/guidance-industry</a>, <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>, or <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Dated: May 31, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-12206 Filed 6-7-23; 8:45 am]
BILLING CODE 4164-01-P
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