Companies may potentially accelerate the approval of generic drugs by avoiding deficiencies in ANDA submissions.
Susan Rosencrance
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Susan Rosencrance, PhD is with the Center for Drug Evaluation and Research, FDA
Articles by Susan Rosencrance
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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Latest Updated Articles
Regulatory Considerations for Controlled Correspondence Related to Generic Drug ChemistryPublished: September 1st 2015 | Updated:
Common Deficiencies in ANDAs for Dermatologic Drug ProductsPublished: September 2nd 2016 | Updated:
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