Andre Raw

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Andre Raw, PhD is with the Center for Drug Evaluation and Research, FDA

Articles

Common Deficiencies in ANDAs for Dermatologic Drug Products

Common Deficiencies in ANDAs for Dermatologic Drug Products

Rong-Kun Chang;Susan Rosencrance;Andre Raw;Bing Cai, PhD;
September 2nd 2016

Companies may potentially accelerate the approval of generic drugs by avoiding deficiencies in ANDA submissions.

Regulatory Considerations for Controlled Correspondence Related to Generic Drug Chemistry

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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