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US FDA Reorg Emphasizes Office of Therapeutic Biologics and Biosimilars

 
• By Brenda Sandburg

Final reorganization structure includes new office within OND to coordinate review of biologics and biosimilars applications, as well as new oncology and hematology divisions.

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The US FDA is elevating the attention given to biologics and biosimilars applications with the establishment of a new Office of Therapeutic Biologics and Biosimilars within its Office of New Drugs.

The new office was highlighted in the agency's final reorganization of the Office of the Commissioner announced March 21. The Office of Therapeutic Biologics and Biosimilars (OTBB) had been mentioned in the proposed reorganization plan announced in July

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