Notice2024-07080
Data Integrity for In Vivo Bioavailability and Bioequivalence Studies; Draft Guidance for Industry; Availability
Primary source
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Published
April 3, 2024
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The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Data Integrity for In Vivo Bioavailability and Bioequivalence Studies." The purpose of this guidance is to provide recommendations to applicants and testing site management on achieving and maintaining data integrity for the clinical and bioanalytical portions of bioavailability (BA) and bioequivalence (BE) studies submitted in support of investigational new drug applications (INDs), new drug applications (NDAs), abbreviated new drug applications (ANDAs), and the bioanalytical portion of clinical pharmacologic studies supporting Center for Drug Evaluation and Research-regulated biologic license applications (BLAs) as well as amendments and supplements to these applications. In addition, the recommendations in this guidance apply to the bioanalytical portion of nonclinical studies. FDA also encourages applicants and testing sites to consider these recommendations when conducting other studies, including in vitro and pharmacology and toxicology studies.
Full Text
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<title>Federal Register, Volume 89 Issue 65 (Wednesday, April 3, 2024)</title>
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[Federal Register Volume 89, Number 65 (Wednesday, April 3, 2024)]
[Notices]
[Pages 23020-23021]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-07080]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-D-1245]
Data Integrity for In Vivo Bioavailability and Bioequivalence
Studies; Draft Guidance for Industry; Availability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the availability of a draft guidance for industry entitled ``Data
Integrity for In Vivo Bioavailability and Bioequivalence Studies.'' The
purpose of this guidance is to provide recommendations to applicants
and testing site management on achieving and maintaining data integrity
for the clinical and bioanalytical portions of bioavailability (BA) and
bioequivalence (BE) studies submitted in support of investigational new
drug applications (INDs), new drug applications (NDAs), abbreviated new
drug applications (ANDAs), and the bioanalytical portion of clinical
pharmacologic studies supporting Center for Drug Evaluation and
Research-regulated biologic license applications (BLAs) as well as
amendments and supplements to these applications. In addition, the
recommendations in this guidance apply to the bioanalytical portion of
nonclinical studies. FDA also encourages applicants and testing sites
to consider these recommendations when conducting other studies,
including in vitro and pharmacology and toxicology studies.
DATES: Submit either electronic or written comments on the draft
guidance by June 3, 2024 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-2024-D-1245 for ``Data Integrity for Bioavailability and
Bioequivalence Studies at Testing Sites.'' 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
[[Page 23021]]
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 draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, 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 draft guidance document.
FOR FURTHER INFORMATION CONTACT: David Coppersmith, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Silver Spring, MD 20993, 301-796-9193.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``Data Integrity for In Vivo Bioavailability and
Bioequivalence Studies.''
Requirements for submitting BA and BE data in INDs, NDAs, ANDAs,
and amendments and supplements to these applications, the definitions
of BA and BE, and the types of in vitro and in vivo studies that are
appropriate to measure BA and establish BE are set forth in parts 312,
314, and 320 (21 CFR parts 312, 314, and 320). Requirements for BLAs
and amendments and supplements to these applications are included in
part 601 (21 CFR part 601). FDA expects that all data submitted to the
Agency, including data from BA and BE studies submitted in support of
INDs, NDAs, and ANDAs and clinical pharmacologic studies submitted in
support of BLAs, are accurate, complete, and reliable, and that
industry maintain data integrity throughout the data lifecycle of the
product(s) or biologic therapeutic(s). In recent years, however, FDA
has observed data integrity concerns during the inspection of testing
sites, clinical testing sites, and analytical testing sites, and during
the assessment of the BA and BE study data submitted in support of
applications. Data integrity concerns can impact application acceptance
for filing, assessment, regulatory actions, and approval as well as
post-approval actions, such as therapeutic equivalence ratings.
This guidance provides recommendations to achieve and maintain data
integrity with respect to (1) applicants, (2) testing site management,
and (3) implementation and management of a quality management system.
This guidance does not include a comprehensive list of all best
practices that applicants and testing sites should use to achieve and
maintain data integrity. It is each applicant's responsibility to
achieve and maintain data integrity for their studies, which includes
identifying and implementing the most effective and efficient risk-
based controls. FDA encourages applicants and testing site management
to review FDA regulations and all applicable guidance for industry to
understand FDA's current thinking on a topic.
This 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 ``Data
Integrity for In Vivo Bioavailability and Bioequivalence Studies.'' 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. The
previously approved collections of information are subject to review by
the Office of Management and Budget (OMB) under the Paperwork Reduction
Act of 1995 (PRA) (44 U.S.C. 3501-3521). The collections of information
in part 312 for investigational new drug applications have been
approved under OMB control number 0910-0014. The collections of
information in part 314 for new drug applications and abbreviated new
drug applications have been approved under OMB control number 0910-
0001. The collections of information in part 601 for biologics license
applications have been approved under OMB control number 0910-0338. The
collections of information found in 21 CFR part 11 pertaining to
electronic records and electronic signatures have been approved under
OMB control number 0910-0303. The collections of information found in
21 CFR parts 50 and 56 pertaining to protection of human subjects,
institutional review boards and informed consent have been approved
under OMB control number 0910-0130. The collections of information in
21 CFR part 58 for good laboratory practices for have been approved
under OMB control number 0910-0119. The collections of information
found in 21 CFR parts 210 and 211 pertaining to current good
manufacturing practice (CGMP) and the recordkeeping requirement for
CGMP sample retention have been approved under OMB control number 0910-
0139.
III. Electronic Access
Persons with access to the internet may obtain the draft guidance
at <a href="https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs">https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs</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: March 29, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-07080 Filed 4-2-24; 8:45 am]
BILLING CODE 4164-01-P
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