In Brief: FDA Refusal-to-File Committee
FDA Refusal-to-File Committee: New procedures will allow RTF recipients to attend the RTF review committee meeting evaluating the RTFs imposed on their applications. The change will be implemented on a trial basis. Companies who have received RTFs may give a presentation and may be questioned by the committee, although they will not be present while CDER explains deficiencies in the company's application to the RTF committee...
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