Notice2022-13520
Assessing the Effects of Food on Drugs in Investigational New Drugs and New Drug Applications-Clinical Pharmacology Considerations; Guidance for Industry; Availability
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Published
June 24, 2022
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 final guidance for industry entitled "Assessing the Effects of Food on Drugs in INDs and NDAs--Clinical Pharmacology Considerations." This guidance provides recommendations to sponsors planning to conduct food-effect (FE) studies for orally administered drug products as part of investigational new drug applications (INDs), new drug applications (NDAs), and supplements to these applications. This guidance finalizes the draft guidance of the same title issued on February 26, 2019.
Full Text
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<title>Federal Register, Volume 87 Issue 121 (Friday, June 24, 2022)</title>
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[Federal Register Volume 87, Number 121 (Friday, June 24, 2022)]
[Notices]
[Pages 37861-37863]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-13520]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-D-4368]
Assessing the Effects of Food on Drugs in Investigational New
Drugs and New Drug Applications--Clinical Pharmacology Considerations;
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 final guidance for industry entitled ``Assessing
the Effects of Food on Drugs in INDs and NDAs--Clinical Pharmacology
Considerations.'' This guidance provides recommendations to sponsors
planning to conduct food-effect (FE) studies for orally administered
drug products as part of investigational new drug applications (INDs),
new drug applications (NDAs), and supplements to these applications.
This guidance finalizes the draft guidance of the same title issued on
February 26, 2019.
DATES: The announcement of the guidance is published in the Federal
Register on June 24, 2022.
ADDRESSES: You may submit either electronic or written comments on
Agency guidances 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
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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-2018-D-4368 for ``Assessing the Effects of Food on Drugs in INDs
and NDAs--Clinical Pharmacology Considerations.'' 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 this 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 guidance document.
FOR FURTHER INFORMATION CONTACT: Vikram Arya or Brian Booth, Center for
Drug Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-1499 or 301-796-
1508.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a guidance for industry
entitled ``Assessing the Effects of Food on Drugs in INDs and NDAs--
Clinical Pharmacology Considerations.'' Food-drug interactions can have
a significant impact on the safety and efficacy of the drug and can be
manifested in different ways. In some cases, co-administration of a
drug with food can increase the systemic exposure of the drug, leading
to improved efficacy or higher rates of adverse reactions. In other
cases, administration of a drug with food can lower the systemic
absorption of a drug, thereby reducing the efficacy. Hence, assessing
the effect of food on the absorption of a drug is critical to optimize
the safety and efficacy of the product and to determine optimum
instructions for drug administration in relation to food.
During new drug development, pharmacokinetic studies to assess the
effect of food on the systemic exposure of the drug are conducted to
determine: (1) if, and to what extent, food impacts the systemic
exposure of the drug; (2) whether food increases or decreases the
variability of the systemic exposure of the drug; and (3) if the effect
of food is different across meals with different fat or caloric
contents. It is important to have as detailed an understanding of the
exposure-response relationships of the drug as possible to interpret
the results of FE studies. Additionally, an understanding of the
various clinical dosing scenarios will be important to characterize the
effect of food and to provide adequate instructions for use of the
drug.
This guidance finalizes the draft guidance entitled ``Assessing the
Effects of Food on Drugs in INDs and NDAs--Clinical Pharmacology
Considerations'' issued on February 26, 2019 (84 FR 6151). FDA
considered comments received on the draft guidance as the guidance was
finalized. Changes from the draft to the final guidance include adding
a discussion of model-informed drug development approaches to assessing
the effects of food on drug exposures and the removal of specific
language regarding the timing of food effect studies and food effect
studies by population pharmacokinetic analysis.
This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on ``Assessing the Effects of Food on Drugs in
INDs and NDAs--Clinical Pharmacology Considerations.'' 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 21 CFR part 314 have been approved under OMB control
number 0910-0001. The collections of information in 21 CFR part 312
have been approved under OMB control number 0910-0014. The collection
of information in 21 CFR parts 50 and 56 have been approved under OMB
control number 0910-0130. The collections of information in 21 CFR
201.56 and 201.57 have been approved under OMB control numbers 0910-
0733 and 0910-0572, and the collections of information related to
pharmacogenomic data have been approved under OMB control number 0910-
0557.
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III. Electronic Access
Persons with access to the internet may obtain the 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: June 17, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-13520 Filed 6-23-22; 8:45 am]
BILLING CODE 4164-01-P
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</html>Indexed from Federal Register on June 24, 2022.
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