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.
Frank Holcombe Jr.
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Frank Holcombe Jr., PhD is with the Center for Drug Evaluation and Research, FDA
Articles by Frank Holcombe Jr.
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Regulatory Considerations for Controlled Correspondence Related to Generic Drug ChemistryPublished: September 1st 2015 | Updated:
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