This guidance provides information regarding the process by which generic drug manufacturers 16 and related industry or their representatives can submit to FDA-controlled correspondence 17 requesting information related to generic drug development. This guidance also describes the 18 Agency’s process for providing communications related to such correspondence.
There are mechanism to communicate with the agency!
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/controlled-correspondence-related-generic-drug-development?utm_medium=email&utm_source=govdelivery
50185759dft.pdf (435.7 KB)