Min Li

Min Li, PhD is with the Center for Drug Evaluation and Research, FDA

Articles

Regulatory Considerations for Controlled Correspondence Related to Generic Drug Chemistry

Geoffrey Wu;Lane Christensen;Thomas O’Connor;Frank Holcombe Jr.;Susan Rosencrance;Andre Raw;Kristina Adams;Xiaochuan Yang;Min Li

September 1st 2015

An analysis of controlled correspondence between generic-drug manufacturers and FDA reveals patterns in questions about specific drug chemistry topics and the response to information provided in FDA guidance documents.

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