Written Requests

Design of the clinical trials for pediatric populations has progressed based on collaborative efforts between the U.S. Food and Drug Administration (FDA) and the National Institutes of Health (NIH) to develop Written Requests (WRs), the formal mechanism by which FDA notifies manufactures of the need to obtain additional clinical information about an off-patent drug for a selected indication in specific populations.

FDA first sends the WR to the manufacturers of the drug. If the manufacturer does not respond to the offer to conduct the clinical trials described in the WR within 30 days, the request is then referred to the NIH for development and conduct of the clinical trial.

Following referral of a WR, the NIH team, led by a senior Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) clinician-scientist, reviews the available literature on the drug. The NIH team, in collaboration with NICHD contracting staff, develops Requests for Proposals (RFPs) that describe in detail the elements of the needed clinical trial. The RFPs are published in the Federal Business Opportunities and resultant proposals are reviewed by an ad-hoc panel of experts convened by the NICHD Division of Scientific Review.

NICHD is currently developing clinical and pre-clinical studies from the following WRs:

WRs are also available online at the Federal Register.