Get Full Government Meeting Transcripts, Videos, & Alerts Forever!
Get email alerts on the Transparency And Legislation topic
No spam. Unsubscribe anytime.
OGD expands transparency on missed goal dates and highlights new legal tool for formulation feedback
Summary
Kozak described an OGD transparency pilot for ANDAs that miss goal dates and said recent Q1/Q2 legislation allows FDA to identify specific inactive-ingredient differences, providing more detailed formulation feedback to applicants.
Kozak described an expanded transparency pilot focused on ANDAs 60 days past their goal dates and said the office now uses enhanced communication and escalation pathways when complex issues arise. She said applicants receive notifications identifying which disciplines may be affected and regular touchpoints with regulatory project managers, and that OGD had only two ANDAs more than 60 days past goal at the time of her remarks.
Separately, Kozak pointed to recent Q1/Q2 legislation enacted in February that enables FDA to identify inactive-ingredient amounts that do not match the reference listed drug; she said FDA has implemented this detailed feedback to pending and submitted ANDAs since the law passed, which should reduce regulatory guesswork for applicants.
