The US Food and Drug Administration (FDA) on Wednesday issued a draft guidance to assist generic drug manufacturers in requesting information from the agency through the controlled correspondence process. The guidance reflects the changes that were part of the reauthorization of the Generic Drug User Fee Amendments (GDUFA III) and expands the topics that are eligible for controlled correspondence as compared to previous iterations of the program.
The GDUFA III commitment letter, issued in November 2021, reflected the performance goals and program enhancements that will guide the program over the next five years (RELATED: GDUFA III commitment letter details coming changes to FDA’s generic review program, Regulatory Focus, 2 November 2021)…
