FDA Office of Regulatory Affairs Realigns Its Work, Adopting a Product-specific Structure

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FDA Office of Regulatory Affairs Realigns Its Work, Adopting a Product-specific Structure

ORA’s 13 Laboratories Also Take on Product Specialties; District Office Framework Retained; Regions Eliminated

Dennis Tosh

FDA Enforcement Manual

May 17, 2017 at 03:55 PM EST

As part of the FDA’s ongoing Program Alignment initiative, the agency’s Office of Regulatory Affairs (ORA), which supervises the agency’s enforcement activities and includes its field operations staff, has implemented a radically different, program-based management structure designed to align the office’s personnel according to specific FDA-regulated product types. The new or... Read More

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FDA Office of Regulatory Affairs Realigns Its Work, Adopting a Product-specific Structure

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