Get Full Government Meeting Transcripts, Videos, & Alerts Forever!
Get email alerts on the Gdufa topic
No spam. Unsubscribe anytime.
FDA: GDUFA commitments led to IID enhancements and quarterly updates
Summary
The presenter outlined how GDUFA commitment letters required IID enhancements (target 10/01/2020) to support MDE queries, described ongoing quarterly updates and reported that MDE population in IID records rose from 4% in July 2020 to 44% currently.
The FDA presenter traced the IID enhancements to GDUFA (Generic Drug User Fee Act) commitments and described how IID content has been expanded and routinely updated. She said the GDUFA II commitment letter included a deadline (10/01/2020) for enhancements enabling users to obtain accurate maximum daily exposure information when data are available.
"GDUFA implemented...to ensure that patients have access to safe, high quality and affordable generic drugs," the agency official said, noting both the original 2012 enactment and later reauthorization that continued the IID commitments. The presenter reported that MDE population in the IID began at about 4% (July 2020) and has increased to about 44% of records.
