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Refuse-to-File Turns 25: New Guidance Changes In Style, But Not Substance

 
• By Ramsey Baghdadi

US FDA’s revised draft guidance spelling out its policy on 'refuse-to-file' decisions differs little in substance compared to predecessor issued in 1993. But difference in style is telling sign of the times.

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The US FDA is replacing its 25 year-old guidance on “Refuse to File” (RTF) decisions for NDA/BLA submissions with a new draft guidance published Dec. 12.

There is very little difference in substance between the new draft and the predecessor guidance issued in 1993. But the guidances are very different in style, changes that reflect...

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