[Federal Register Volume 88, Number 185 (Tuesday, September 26, 2023)]
[Notices]
[Pages 66008-66009]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-20903]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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 https://www.fda.gov/about-fda/visitor-information.

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, [email protected].

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: https://www.eventbrite.com/e/adept-8-pediatric-renal-impairment-workshop-tickets-687423571407. 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 [email protected] 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 https://zoom.us/test. 
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 https://www.regulations.gov. 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