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October 1, 2018

FDA pediatric IBD workshop

The FDA will be hosting a workshop on Friday, Nov. 16, to discuss current barriers to expeditious pediatric inflammatory bowel disease (IBD) drug development and steps to overcome them.

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This workshop is open to the public with no cost to attend, but registration is still required. Clinicians, investigators, patients and parents of patients, device manufacturers, pharmaceutical companies, contract research organizations and regulators are encouraged to attend.

 

Goals and objectives:

 

    • The aim of the workshop will be to discuss current barriers to expeditious pediatric IBD drug development and steps to overcome them.

 

    • Specific topics will include a review of the legislation relevant to pediatric trials, extrapolation, trial design considerations, dose selection and the level of evidence required to establish safety and effectiveness in pediatric patients with IBD.

 

 

The workshop will be held at:

 

FDA’s White Oak Campus

10903 New Hampshire Avenue

Building #31 – Room 1503A

Silver Spring, MD 20903

* Remote viewing available

 

Visit the workshop website to register and for more information.

 

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