[Federal Register Volume 83, Number 149 (Thursday, August 2, 2018)]
[Notices]
[Pages 37816-37817]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-16524]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-2657]


Advancing the Development of Pediatric Therapeutics 5: Advancing 
Pediatric Pharmacovigilance; Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

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SUMMARY: The Division of Pediatric and Maternal Health, Office of 
Surveillance and Epidemiology, and Office of Pediatric Therapeutics, 
Food and Drug Administration (FDA or the Agency) are announcing a 
public workshop entitled ``Advancing the Development of Pediatric 
Therapeutics 5: Advancing Pediatric Pharmacovigilance.'' The purpose of 
this 1-day workshop is to provide a forum to gather information on the 
latest developments in pediatric pharmacovigilance from the perspective 
of various stakeholders and to expand the conversation to include the 
utility and challenges of emerging pharmacovigilance tools, including 
specific challenges associated with pediatric data tools.

DATES: The public workshop will be held on Friday, September 14, 2018, 
from 8 a.m. to 5 p.m. See the SUPPLEMENTARY INFORMATION section for 
registration date and information.

ADDRESSES: The public workshop will be held at FDAWhite Oak Campus, 
10903 New Hampshire Ave. Bldg. 31 Conference Center, the Great Room 
(Rm. 1503A), Silver Spring, MD 20993. Entrance for the 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/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.

FOR FURTHER INFORMATION CONTACT: For questions regarding the workshop, 
contact Denise Pica-Branco, Center for Drug Evaluation and Research, 
Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, 
MD 20993-0002, 301-796-1732, [email protected]; or Meshaun 
Payne, Center for Drug Evaluation and Research, Food and Drug 
Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 
301-796-6668, [email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    Drugs and biologics (products) receive marketing approval only 
after undergoing premarket review and upon establishment of safety and 
efficacy through adequate and well-controlled clinical trials. Because 
all safety issues related to a product may not be detected in the 
premarket phase, FDA receives and analyzes postmarket safety 
information to determine if events reported in the postmarketing period 
are likely to be related to exposure to a product. When FDA determines 
that reported postmarketing events are likely related to a product, FDA 
can introduce labeling changes and other activities to inform the 
professional and lay public.

[[Page 37817]]

    FDA receives reports through the MedWatch website (https://www.fda.gov/Safety/MedWatch/HowToReport/default.htm), which are then 
entered into the FDA Adverse Event Reporting System for subsequent 
analysis. Because the volume of reports is large and because reporting 
entities (product manufacturers and the professional or lay public) 
need only suspect a possible link between product exposure and an 
adverse event, FDA employs specific tools and strategies to assess 
postmarket safety reports and potential signals that arise from review 
of these reports. The process for receipt and assessment of such 
postmarket safety information is referred to as pharmacovigilance.
    FDA has a specific regulatory mandate to perform pediatric 
pharmacovigilance and to present or make available the results of such 
pediatric pharmacovigilance to the Pediatric Advisory Committee.

II. Topics for Discussion at the Public Workshop

    In this workshop, FDA will gather information on the latest 
developments in pediatric pharmacovigilance from the perspective of 
various stakeholders and expand the conversation to include the utility 
and challenges of emerging pharmacovigilance tools, including specific 
challenges associated with pediatric data tools.

III. Participation in the Public Workshop

    Registration: Persons interested in attending this public workshop 
must register online at https://www.eventbrite.com/e/advancing-the-development-of-pediatric-therapeutics-5-adept5-tickets-46654530958 by 
Thursday, September 6, 2018, midnight Eastern Time. Please provide 
complete contact information for each attendee, including name, title, 
affiliation, address, email, and telephone. Onsite registration will 
not be available.
    Registration for onsite participation or via webcast is free and 
based on space availability, with priority given to early registrants. 
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 Denise Pica-Branco ([email protected]) or Meshaun 
Payne ([email protected]) no later than Thursday, September 6, 
2018.
    Streaming Webcast of the Public Workshop: Webcast information will 
be provided after participants have registered for the workshop. If you 
have never attended a Connect Pro event before, test your connection at 
https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. 
To get a quick overview of the Connect Pro program, visit https://www.adobe.com/go/connectpro_overview.
    FDA has verified the website addresses in this document, as of the 
date this document publishes in the Federal Register, but websites are 
subject to change over time.

    Dated: July 27, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-16524 Filed 8-1-18; 8:45 am]
 BILLING CODE 4164-01-P