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Gottlieb's Complex Generics Remarks Could Signal (Some) Increased Flexibility

 
• By Michael Cipriano

US FDA commissioner spoke to agency scientists and researchers at Generic Drug Science Day, where he discussed future plans to facilitate complex generic development.

US FDA Commissioner Scott Gottlieb's remarks on generic copies of products with drug and device constituent parts could signal a degree of increased flexibility on the part of the Office of Generic Drugs (OGD) in allowing labeling differences between the generic and innovator product, experts say.

Speaking Nov. 28 at Generic Drug Science Day, an internal FDA event for agency scientists and researchers, Gottlieb reinforced the agency's position to permit a generic product to have certain...

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