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US FDA's Stein Outlines Functions Of Rare Disease, Inborn Error Groups In New OND Division

 
• By Michael Cipriano

Office of New Drugs director Peter Stein shed some light on how the newly established Division of Rare Diseases and Medical Genetics will operate following the completion of the OND reorganization, drawing mixed reactions from industry speakers.

FDA entrance sign 2016

The soon-to-be established Division of Rare Diseases and Medical Genetics (DRDMG) will feature both a consultative rare disease group and an inborn errors group that reviews product applications, Office of New Drugs (OND) director Peter Stein explained.

During a panel discussion last month at the FDA/CMS Summit sponsored by the Pink Sheet's parent company Informa, Stein explained...

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