Notice2023-02479
Understanding Priorities for the Development of Digital Health Technologies To Support Clinical Trials for Drug Development and Review; Public Workshop
Primary source
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Published
February 6, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA) is announcing the following public workshop entitled "Understanding Priorities for the Development of Digital Health Technologies To Support Clinical Trials for Drug Development and Review." Convened by the Duke-Robert J. Margolis, MD Center for Health Policy and supported by a cooperative agreement between FDA and Duke-Margolis, the purpose of the public workshop is to understand the priorities for the development of Digital Health Technologies (DHTs) to support clinical drug trials, including accessibility, diversity, and clinical outcome measures using DHTs. Additionally, this public workshop meets a Prescription Drug User Fee Amendments (PDUFA VII) commitment to convene the first of a series of public workshops by the end of the second quarter (Q2), fiscal year (FY) 2023.
Full Text
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<title>Federal Register, Volume 88 Issue 24 (Monday, February 6, 2023)</title>
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[Federal Register Volume 88, Number 24 (Monday, February 6, 2023)]
[Notices]
[Pages 7738-7739]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-02479]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-0043]
Understanding Priorities for the Development of Digital Health
Technologies To Support Clinical Trials for Drug Development and
Review; Public Workshop
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
following public workshop entitled ``Understanding Priorities for the
Development of Digital Health Technologies To Support Clinical Trials
for Drug Development and Review.'' Convened by the Duke-Robert J.
Margolis, MD Center for Health Policy and supported by a cooperative
agreement between FDA and Duke-Margolis, the purpose of the public
workshop is to understand the priorities for the development of Digital
Health Technologies (DHTs) to support clinical drug trials, including
accessibility, diversity, and clinical outcome measures using DHTs.
Additionally, this public workshop meets a Prescription Drug User Fee
Amendments (PDUFA VII) commitment to convene the first of a series of
public workshops by the end of the second quarter (Q2), fiscal year
(FY) 2023.
DATES: The public workshop will be held virtually on March 28, 2023,
and March 29, 2023, from 1 p.m. to 5 p.m., Eastern Time. See the
SUPPLEMENTARY INFORMATION section for registration date and
information.
ADDRESSES: The public workshop will be held virtually using the Zoom
[[Page 7739]]
Platform. The link for the public workshop will be sent to registrants
upon registration.
FOR FURTHER INFORMATION CONTACT: Capt. Dianne Paraoan, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 3326, Silver Spring, MD 20993, 301-796-
3161, <a href="/cdn-cgi/l/email-protection#d296bbb3bcbcb7fc82b3a0b3bdb3bc92b4b6b3fcbabaa1fcb5bda4"><span class="__cf_email__" data-cfemail="35715c545b5b501b655447545a545b755351541b5d5d461b525a43">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
The seventh iteration of the Prescription Drug User Fee Amendments
(PDUFA VII), included as part of the FDA User Fee Reauthorization Act
of 2022, highlights the goals of facilitating timely access to safe,
effective, and innovative new medicines for patients. The commitments
in the PDUFA Reauthorization Performance Goals and Procedures Fiscal
Years 2023 Through 2027 document (available at: <a href="https://www.fda.gov/industry/prescription-drug-user-fee-amendments/pdufa-vii-fiscal-years-2023-2027">https://www.fda.gov/industry/prescription-drug-user-fee-amendments/pdufa-vii-fiscal-years-2023-2027</a>) focus on activities to enhance the use of DHTs to support
drug development and review, including working with the Digital Health
Center of Excellence.
To meet a PDUFA VII commitment, FDA agreed to convene a series of
five public workshops with key stakeholders including patients,
biopharmaceutical companies, DHT companies, and academia to gather
input into issues related to the use of DHTs in regulatory decision-
making. The objective of this first workshop is to understand
priorities for the development of DHTs to support clinical drug trials,
including the potential for DHTs to increase clinical trial
accessibility and diversity, as well as the use of DHTs to capture
clinical outcome measures. The public workshop scheduled for March 28
and 29, 2023, fulfills the commitment to convene the first of a series
of five public workshops by the end of Q2, FY 2023.
II. Topics for Discussion at the Public Workshop
At the public workshop, FDA plans to discuss with stakeholders
priorities and challenges for the development of DHTs to support
clinical drug trials, including, but not limited to:
<bullet> improving participant access, increasing diversity, and
facilitating engagement through remote trial-related measurements;
<bullet> understanding patient and industry perspectives;
<bullet> understanding opportunities for remote data acquisition
directly from trial participants; and
<bullet> using DHTs to capture clinical outcomes measures.
III. Participating in the Public Workshop
Registration: To register for the public workshop, please visit the
following website: <a href="https://duke.is/pzkwx">https://duke.is/pzkwx</a>. Please provide complete
contact information for each attendee, including name, title,
affiliation, and email.
Registration is free and people interested in attending this public
workshop must register to receive a link to the meeting. Registrants
will receive a confirmation email after they register.
If you need special accommodations, please contact
<a href="/cdn-cgi/l/email-protection#d39eb2a1b4bcbfbaa0b6a5b6bda7a093b7a6b8b6fdb6b7a6"><span class="__cf_email__" data-cfemail="105d7162777f7c79637566757e64635074657b753e757465">[email protected]</span></a> no later than March 7, 2023. Please note,
closed captioning will be available automatically.
Dated: February 1, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-02479 Filed 2-3-23; 8:45 am]
BILLING CODE 4164-01-P
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