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US FDA's Program Alignment: Where Should Form-483 Responses Go After May 15?

 
• By Bowman Cox and Shawn M. Schmitt

Now that FDA is aligning its enforcement program with its product centers on May 15, there are questions about who in the agency should receive manufacturers' 15-day responses to Form-483 inspectional observations.

Pharmaceutical manufacturers will face a new challenge in responding to inspectional observations after US FDA aligns its Office of Regulatory Affairs field organization with the agency's product-oriented centers on May 15.

They won't know who should receive their responses to Form-483 inspectional findings.

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