Review of Drug Master Files in Advance of Certain ANDA Submissions Under GDUFA
Review of Drug Master Files in Advance of Certain ANDA Submissions Under GDUFA. The Generic Drug User Fee Amendments (GDUFA) provides a framework for improving the efficiency and transparency of the review process for generic drug applications, known as Abbreviated New Drug Applications (ANDAs). One key aspect of this framework is the review of Drug Master Files (DMFs), which are critical for ANDA submissions involving drug substances, intermediates, or excipients that are not fully described in the ANDA itself.
HSA releases New Initiatives for Registration of Therapeutic Products- Aug 2021
As part of HSA’s ongoing efforts to enhance clarity in regulatory requirements and processes, and make regulatory information easily accessible to encourage good submission practices by the industry, the HSA has introduced an online self-guided tool for post-approval minor variations application and a DMF acknowledgment email and guidance on deficiency matters.