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Drug Review Reorganization At US FDA Coming Into Focus

 
• By Nielsen Hobbs

Oncology, neuroscience, and infectious diseases get acting directors as the expansion and renovation of the Office of New Drugs moves into Phase II.

The reorganization of the US Food and Drug Administration's new drugs review program is proceeding into its second phase as the agency announced the acting leadership of three new offices within the Office of New Drugs.

"Some applications (e.g., INDs, NDAs, BLAs) may be affected during Phase II," the agency noted. "If there is a change in signatory or point of contact for applications currently under...

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