CHPA “approvable”letter comments
This article was originally published in The Tan Sheet
Executive Summary
FDA "should clearly define specific deficiencies" in an application in a complete response letter, the Consumer Healthcare Products Association says in Oct. 18 comments on the agency's proposed rule to discontinue use of "approvable" and "not approvable" letters. Defining deficiencies "would avoid presentation of new issues at a later date after a complete response letter has been issued, and minimize the potential for cycles of complete response letters," CHPA states. The association "supports" FDA's proposal to use complete response letters once the review cycle is complete but an application is not ready for approval. The proposed reg was published in July (1"The Tan Sheet" July 26, 2004, p. 11)...