- November 21, 2019
9:00 AM - 3:00 PM ET
Event LocationWhite Oak Campus: The Great Room
10903 New Hampshire Ave
Building 31, Room 1503
Silver Spring, MD 20993
- Organized By:
The Food and Drug Administration (FDA) is announcing a public meeting entitled “Pediatric Stakeholder Meeting.”
The purpose of this public meeting is for FDA to obtain input from patient groups, consumer groups, regulated industry, academia and other interested parties on any recommendations or information relevant to the report to Congress that FDA is required to submit to Congress as outlined in section 508 of the Food and Drug Administration Safety and Innovation Act (FDASIA). Some of the issues to be discussed at the meeting will include, but not be limited to:
- Hearing from patients/parents and patient/parent groups, industry, academia and other stakeholders about the public health impact that pediatric legislation may have had on them or their communities;
- Understanding the effects of the requirement of pediatric studies under PREA or the incentives under BPCA on drug/biologic development plans; and
- Understanding if there are any barriers or resource issues preventing undertaking or completing studies under PREA and BPCA.
The public meeting will be held at the FDA White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the Great Room (1503-A), Silver Spring, MD 20993-0002. Entrance for the public workshop participants (non-FDA employees) is through Bldg. 1 where routine security check procedures will be performed. For parking and security information, please refer to Public Meetings at the FDA White Oak Campus.
To register for this meeting, visit: https://www.eventbrite.com/e/stakeholder-input-on-pediatric-legislation-tickets-74306461627. Seating will be limited so please register before close of business on November 15, 2019.
Submitting Comments to the Public Docket:
In addition to providing input at the public meeting, stakeholders are invited to provide their comments through the public docket. The docket closes on December 19, 2019.
Visit the following website to submit your comments: Notice of public meeting; request for comments (Docket number FDA-2019-N-4560)
- Federal Register Notice (October 25, 2019)
- Transcript (to be posted after the meeting)
To view the Webcast, please visit: https://collaboration.fda.gov/pediatriclegislation/
For questions regarding the meeting please contact:
Terrie L. Crescenzi, RPH, Office of Pediatric Therapeutics, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993–0002, 301–796–8646, FAX: 301–847–8640, email: firstname.lastname@example.org or Elizabeth Sanford, Office of Pediatric Therapeutics, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-8659, FAX: 301-847-8640, email: email@example.com.
|Agenda, Pediatric Stakeholder Public Meeting, November 21, 2019||pdf (76.56 KB)|
|Katie Coester, EGPAF Presentation||pdf (2.38 MB)|
|Ed Conner, IACT Presentation||pdf (825.94 KB)|
|Jonathan Davis, Tufts/CTSA Presentation||pdf (1.34 MB)|
|Danielle Friend, BIO Presentation||pdf (567.35 KB)|
|Bridget Jones, AAP Presentation||pdf (876.95 KB)|
|Denise Schulz-AbbVie, BIO Presentation||pdf (542.04 KB)|
|Perdita Taylor-Zapata, NICHD Presentation||pdf (1.38 MB)|
|Brenda Weigel, COG Presentation||pdf (2.48 MB)|
|Susan McCune, FDA Presentation||pdf (1.08 MB)|