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FDA: Send Us Your Pediatric Oncology Drugs

Posted 07 August 2012 | By

The US Food and Drug Administration (FDA) is calling for the submission of pharmaceutical and biological products worthy of being brought before its Pediatric Subcommittee of the Oncologic Drugs Advisory Committee (ODAC) on 4 December 2012.

ODAC is a 13-member committee charged with reviewing and evaluating data regarding the safety and effectiveness of cancer fighting drugs. Its pediatric subcommittee places an emphasis on oncology products intended for children-a product area traditionally underserved by product development.

In its 7 August Federal Register notice, FDA said ODAC is no longer experiencing these availability issues to the extent it once did, but is still looking to areas of critical need. "We see a reduction in off-label use," remarked FDA, noting this is the result of additional studies using pediatric populations and not a reduction in use.

"We would like to improve current and future pediatric product development by focusing on products whose development would benefit the most from the attention of an advisory committee," wrote FDA.

The agency said the company brought before the committee would be given a, "Unique opportunity to present proposed pediatric studies," in both the US and around the world for ODAC discussion.


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