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FDA News Issue 18 July 2019

Published on 7/10/2019 1:05:00 PM


FDA Announces a Public Workshop Entitled "Accelerating Drug Development for Polyarticular Juvenile Idiopathic Arthritis (pJIA)" for October 2, 2019

The US Food and Drug Administration (FDA) in collaboration with the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI), will host a one-day public workshop entitled "Accelerating Drug Development for Polyarticular Juvenile Idiopathic Arthritis (pJIA)" on October 2, 2019.
 
The objectives of this workshop are to:

  1. Discuss the current barriers to expeditious pJIA drug development and steps to overcome them.
  2. Discuss specific topics related to extrapolation, trial design considerations, dose selection, modeling and simulation, and level of evidence required to establish safety and effectiveness in pediatric patients with pJIA. 
Clinicians, investigators, clinical pharmacologists, patients and parents of patients, device manufacturers, pharmaceutical companies, contract research organizations, non-profit organizations focused on arthritis, regulators, etc. are encouraged to attend. 
 
The date, time, location, and other details of the workshop are as follows:
Date: October 2, 2019
Time: 8:00 AM - 5:00 PM
Location: FDA's White Oak Campus, 10903 New Hampshire Avenue, Building 31, Silver Spring, MD 20993
 
Additional information about this workshop, including registration, webcast instructions, and parking and directions, is available at https://go.usa.gov/xy2ec.
 
Registration to attend in-person or view the webinar is free. Individuals who wish to view the webcast are still required to complete registration for the conference.

If you have any additional questions about this workshop, please contact cersi@umd.edu.


The Office of Clinical Pharmacology (OCP) is pleased to offer the e-mail subscription service Clinical Pharmacology Corner. This is a free service from FDA to provide occasional updates from OCP regarding newly approved therapies, new regulatory and scholarly publications, upcoming events and other items of interest. Subscribe today at http://go.fda.gov/subscriptionmanagement (note: this link does not work with Internet Explorer) and select Clinical Pharmacology Corner under Drugs.

We always welcome your thoughts regarding the format, content, and utility of this communication. Comments may be sent via email to ocp@fda.hhs.gov.

This communication was prepared by Office of Clinical Pharmacology, Office of Translational Sciences, CDER, FDA.

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