Learning the GDUFA II Language

Although the generic industry has come a long way in terms of Quality-by-Design or the desired space, it is still in early stages when it comes to Dates and Abbreviations as they relate to GDUFA.  It has been a little overwhelming to the participants of this year’s Association of Accessible Medicines (AAM) Fall Technical Conference in Bethesda,

Do You Have a Story to Tell?

Giuseppe Randazzo, the Director of the Office of Program and Regulatory Operations, urged the generic industry to tell a story in a cover letter when sending a submission to FDA. Yes, that’s right.  At his presentation in Bethesda at the Association of Accessible Medicines 2017 Fall Technical Conference, Mr. Randazzo explained that a cover letter,