
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.
Geoffrey Wu, PhD*, is a regulatory review officer, geoffrey.wu@fda.hhs.gov.

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.

Published: September 1st 2015 | Updated: