A quiet FDA reorg

Buried in boilerplate language is a revolutionary shift in regulatory policy at the FDA, writes Peter Pitts, president of the think tank Center for Medicine in the Public Interest. 

Pitts, who also once served as an FDA associate commissioner, writes that a recent press release titled “Reorganization of the Office of New Drugs with Corresponding Changes to the Office of Translational Sciences and the Office of Pharmaceutical Quality” indicates important and noteworthy change at the agency. 

For instance, there will be more folks conducting product and clinical review. And it’ll shore up and centralize drug policy review in the Office of New Drug Policy. These changes show that “laying claim to the regulatory gold standard is a moving target,” Pitts writes. 

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