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Question-Based Review Not Raising Questions For Generic Sponsors, FDA

Executive Summary

Initial experiences with question-based reviews of the chemistry, manufacturing and controls section of ANDAs suggest the quality initiative will not adversely affect the generics review process for sponsors

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ANDA question-based-review adherence

More than 90 percent of ANDA submissions include quality overall summaries as of July, FDA reports. The agency requested in January that generic drug applications include a quality overall summary that answers questions related to the ANDA's Chemistry, Manufacturing and Controls section. Over the span of seven months, that number has increased dramatically, showing a positive response to the agency's use of question-based reviews. Although the goals, implemented in 2005 as a pilot program, caused some generic firms to express concern that QbR would extend review periods and provide FDA more opportunity to find fault with applications, initial experiences with the program have not shown such adverse effects (1"The Pink Sheet" Nov. 13, 2006, p. 17)...

ANDA question-based-review adherence

More than 90 percent of ANDA submissions include quality overall summaries as of July, FDA reports. The agency requested in January that generic drug applications include a quality overall summary that answers questions related to the ANDA's Chemistry, Manufacturing and Controls section. Over the span of seven months, that number has increased dramatically, showing a positive response to the agency's use of question-based reviews. Although the goals, implemented in 2005 as a pilot program, caused some generic firms to express concern that QbR would extend review periods and provide FDA more opportunity to find fault with applications, initial experiences with the program have not shown such adverse effects (1"The Pink Sheet" Nov. 13, 2006, p. 17)...

ANDA Review Improvements Continue As FDA Eyes Generic User Fee Resources

FDA's review backlog for ANDAs requires a "significant" improvement in resources, Office of Generic Drugs Director Gary Buehler said

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