Notice2023-20903
Advancing the Development of Pediatric Therapeutics on Drug Dosing in Pediatric Patients With Renal Impairment; Public Workshop
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
September 26, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public workshop entitled "Advancing the Development of Pediatric Therapeutics (ADEPT 8) on Drug Dosing in Pediatric Patients With Renal Impairment." The purpose of the public workshop is to discuss the current landscape of drug dosing in pediatric patients with renal impairment, understand the gaps in knowledge, and consider innovative approaches to improve the current paradigm for dosing in pediatric patients with renal impairment.
Full Text
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<title>Federal Register, Volume 88 Issue 185 (Tuesday, September 26, 2023)</title>
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[Federal Register Volume 88, Number 185 (Tuesday, September 26, 2023)]
[Notices]
[Pages 66008-66009]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-20903]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-0001]
Advancing the Development of Pediatric Therapeutics on Drug
Dosing in Pediatric Patients With Renal Impairment; Public Workshop
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop.
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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
announcing the following public workshop entitled ``Advancing the
Development of Pediatric Therapeutics (ADEPT 8) on Drug Dosing in
Pediatric Patients With Renal Impairment.'' The purpose of the public
workshop is to discuss the current landscape of drug dosing in
pediatric patients with renal impairment, understand the gaps in
knowledge, and consider innovative approaches to improve the current
paradigm for dosing in pediatric patients with renal impairment.
DATES: The public workshop will be held on November 30, 2023, and
December 1, 2023, from 9 a.m. to 5 p.m. eastern time each day. See the
SUPPLEMENTARY INFORMATION section for registration date and
information.
ADDRESSES: The public workshop will be held at the FDA White Oak Campus
Great Room and online. Entrance for the registered public workshop
participants (non-FDA employees) is through Building 1 where routine
security check procedures will be performed. For parking and security
information, please refer to <a href="https://www.fda.gov/about-fda/visitor-information">https://www.fda.gov/about-fda/visitor-information</a>.
FOR FURTHER INFORMATION CONTACT: Julie Levin, Office of New Drugs
Public Meeting Support, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 6481, Silver Spring, MD 20993-0002, 202-
567-7565, <a href="/cdn-cgi/l/email-protection#dd9293998da8bfb1b4be90899a8ea8adadb2afa99dbbb9bcf3b5b5aef3bab2ab"><span class="__cf_email__" data-cfemail="8cc3c2c8dcf9eee0e5efc1d8cbdff9fcfce3fef8cceae8eda2e4e4ffa2ebe3fa">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
The pharmacokinetics of drugs excreted by the kidneys may be
altered by renal (kidney) impairment, requiring dosing adjustments.
However, the majority of drugs that are predominantly renally excreted
and have dosage recommendations for adults with renal impairment lack
dose adjustment recommendations for pediatric patients with renal
impairment. This is largely due to the lack of generation of
pharmacokinetic data in pediatric patients with renal impairment, which
is attributable to both the ethical and the practical limitations of
conducting dedicated renal impairment studies in pediatric patients, as
well as the exclusion of pediatric patients with renal impairment from
most clinical efficacy and safety studies. For drugs that are renally
cleared, exposures can be impacted by both the maturation of kidney
function and the renal impairment due to kidney disease.
II. Topics for Discussion at the Public Workshop
The main objective of the ``Advancing the Development of Pediatric
Therapeutics (ADEPT 8) on Drug Dosing in Pediatric Patients With Renal
Impairment'' workshop is to discuss current approaches to classifying
renal impairment in the pediatric population, identify data gaps, and
explore scientifically supported approaches and methods for providing
information on dosing adjustment. The workshop will specifically focus
on measurements of renal function, extrapolation of adult data, and
approaches to generating clinical trial data to assess the impact of
renal impairment on the pharmacokinetics of drugs in pediatric
patients. In addition, the workshop will allow for an open dialogue
around the use of these approaches among regulators, industry,
academia, and patient organizations.
III. Participating in the Public Workshop
Registration: To register for the public workshop, please visit the
following website: <a href="https://www.eventbrite.com/e/adept-8-pediatric-renal-impairment-workshop-tickets-687423571407">https://www.eventbrite.com/e/adept-8-pediatric-renal-impairment-workshop-tickets-687423571407</a>. Please provide complete
contact information for each attendee, including name, title,
affiliation, address, email, and telephone.
Registration is free and based on space availability, with priority
given to early registrants. Persons interested in attending this public
workshop must register by November 15, 2023, 11:59 p.m. Eastern Time.
Early registration is recommended because seating is limited;
therefore, FDA may limit the number of participants from each
organization. Registrants will receive confirmation when they have been
accepted.
If you need special accommodations due to a disability, please
contact Julie Levin at <a href="/cdn-cgi/l/email-protection#bbf4f5ffebced9d7d2d8f6effce8cecbcbd4c9cffbdddfda95d3d3c895dcd4cd"><span class="__cf_email__" data-cfemail="115e5f554164737d78725c4556426461617e6365517775703f7979623f767e67">[email protected]</span></a> no later than
November 15, 2023.
Streaming Webcast of the Public Workshop: This public workshop will
also be via Zoom. A link will be provided via email to registered
participants. If you have never attended a Zoom event before, test your
internet connection by joining a test meeting at <a href="https://zoom.us/test">https://zoom.us/test</a>.
FDA has verified the website addresses in this document, as of the date
this document is published in the Federal Register, but websites are
subject to change over time.
Transcripts: Please be advised that when a transcript of the public
workshop is available, it will be accessible at <a href="https://www.regulations.gov">https://www.regulations.gov</a>. It may be viewed at the Dockets Management Staff
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
[[Page 66009]]
Dated: September 21, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-20903 Filed 9-25-23; 8:45 am]
BILLING CODE 4164-01-P
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