Notice2023-11751
Migraine: Developing Drugs for Preventive Treatment; Draft Guidance for Industry; Availability
Primary source
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Published
June 2, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled "Migraine: Developing Drugs for Preventive Treatment." This draft guidance document is intended to assist sponsors in the clinical development of drugs for the preventive treatment of migraine. The draft guidance is intended to complement, not replace, the guidance for industry "Migraine: Developing Drugs for Acute Treatment," and focuses on specific drug development and trial design issues that are unique to the study of drugs for the preventive treatment of migraine. This draft guidance is intended to serve as a focus for continued discussions among FDA's Division of Neurology II, sponsors, the academic community, and the public.
Full Text
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<title>Federal Register, Volume 88 Issue 106 (Friday, June 2, 2023)</title>
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[Federal Register Volume 88, Number 106 (Friday, June 2, 2023)]
[Notices]
[Pages 36321-36322]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-11751]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-D-1729]
Migraine: Developing Drugs for Preventive Treatment; Draft
Guidance for Industry; Availability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, Agency, or we) is
announcing the availability of a draft guidance for industry entitled
``Migraine: Developing Drugs for Preventive Treatment.'' This draft
guidance document is intended to assist sponsors in the clinical
development of drugs for the preventive treatment of migraine. The
draft guidance is intended to complement, not replace, the guidance for
industry ``Migraine: Developing Drugs for Acute Treatment,'' and
focuses on specific drug development and trial design issues that are
unique to the study of drugs for the preventive treatment of migraine.
This draft guidance is intended to serve as a focus for continued
discussions among FDA's Division of Neurology II, sponsors, the
academic community, and the public.
DATES: Submit either electronic or written comments on the draft
guidance by August 1, 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-2022-D-1729 for ``Migraine: Developing Drugs for Preventive
Treatment.'' 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
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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: Heather Fitter, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 4362, Silver Spring, MD 20993, 301-796-
3984.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``Migraine: Developing Drugs for Preventive Treatment.'' The
draft guidance is intended to assist sponsors with developing drugs for
the preventive treatment of migraine. The draft guidance provides FDA's
current thinking regarding the overall development program and clinical
trial designs to support approval of drugs for the preventive treatment
of migraine.
Migraine is a chronic neurovascular disorder characterized by
recurrent attacks of often severe headache, typically accompanied by
nausea and sensitivity to light and/or sound. Pharmacological
approaches to the treatment of migraine include drugs to abort migraine
attacks as they arise (acute treatment of migraine) and drugs to reduce
the frequency of migraine attacks (preventive treatment). This draft
guidance addresses the development of drugs for the preventive
treatment of migraine, including trial population, trial design, dose
selection, efficacy endpoints, and statistical considerations. This
draft guidance does not address the development of drugs intended for
the acute treatment of migraine, as this has been covered by the
previously published guidance for industry ``Migraine: Developing Drugs
for Acute Treatment,'' available at <a href="https://www.fda.gov/media/89829/download">https://www.fda.gov/media/89829/download</a>.\1\
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\1\ We update guidances periodically. For the most recent
version of a guidance, check the FDA guidance web page at <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>.
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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 ``Migraine:
Developing Drugs for Preventive Treatment.'' 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 201 have been approved under OMB control
number 0910-0572, and the collections of information in 21 CFR part 312
have been approved under OMB control number 0910-0014.
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: May 30, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-11751 Filed 6-1-23; 8:45 am]
BILLING CODE 4164-01-P
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