Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments; Draft Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders; Availability; Correction
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Abstract
The Food and Drug Administration (FDA) is correcting a notice entitled "Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments; Draft Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders; Availability" that appeared in the Federal Register of June 30, 2022. The document announced the publication of a draft guidance, the third in a series of four methodological patient-focused drug development guidance documents that describe how stakeholders (patients, researchers, medical product developers, and others) can collect and submit patient experience data and other relevant information from patients and caregivers to be used for medical product development and regulatory decision-making. The document was published with the incorrect docket number. This document corrects that error.
Full Text
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<title>Federal Register, Volume 87 Issue 131 (Monday, July 11, 2022)</title>
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[Federal Register Volume 87, Number 131 (Monday, July 11, 2022)]
[Notices]
[Page 41135]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-14677]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-D-1385]
Patient-Focused Drug Development: Selecting, Developing, or
Modifying Fit-for-Purpose Clinical Outcome Assessments; Draft Guidance
for Industry, Food and Drug Administration Staff, and Other
Stakeholders; Availability; Correction
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; correction.
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SUMMARY: The Food and Drug Administration (FDA) is correcting a notice
entitled ``Patient-Focused Drug Development: Selecting, Developing, or
Modifying Fit-for-Purpose Clinical Outcome Assessments; Draft Guidance
for Industry, Food and Drug Administration Staff, and Other
Stakeholders; Availability'' that appeared in the Federal Register of
June 30, 2022. The document announced the publication of a draft
guidance, the third in a series of four methodological patient-focused
drug development guidance documents that describe how stakeholders
(patients, researchers, medical product developers, and others) can
collect and submit patient experience data and other relevant
information from patients and caregivers to be used for medical product
development and regulatory decision-making. The document was published
with the incorrect docket number. This document corrects that error.
FOR FURTHER INFORMATION CONTACT: Lisa Granger, Office of Policy,
Planning, Legislation and International Affairs, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 3330, Silver
Spring, MD 20993-0002, 301-796-9115, email: <a href="/cdn-cgi/l/email-protection#501c3923317e1722313e373522103634317e3838237e373f26"><span class="__cf_email__" data-cfemail="f4b89d8795dab386959a939186b4929095da9c9c87da939b82">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: In the Federal Register of Friday, June 30,
2022 (87 FR 39101), in FR Doc. 2022-13952, the following corrections
are made:
1. On page 39101, in the third column in the header of the
document, ``Docket No. FDA-2018-N-2455'' is corrected to read ``Docket
No. FDA-2022-D-1385.''
2. On page 39102, in first column in ``Instructions,'' ``Docket No.
FDA-2018-N-2455'' is corrected to read ``Docket No. FDA-2022-D-1385.''
Dated: July 5, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-14677 Filed 7-8-22; 8:45 am]
BILLING CODE 4164-01-P
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