Frank Holcombe Jr.
Frank Holcombe Jr., 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 2015An 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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