Get Full Government Meeting Transcripts, Videos, & Alerts Forever!
Get email alerts on the Gdufa Iii topic
No spam. Unsubscribe anytime.
FDA explains 'prior assessment' DMF pathway under GDUFA III
Summary
Agency official described prior assessment requests—submissions that request assessment before an ANDA is filed under GDUFA III—and advised submitters to follow the guidance appendix checklist to avoid missing information and delays.
The presenter explained that prior assessment requests are a relatively new submission type under GDUFA III that allow DMF evaluation before an ANDA is received. She said these DMFs must meet criteria in the commitment letter and guidance appendix and that including the appendix checklist items reduces back-and-forth communications and speeds the agency response.
She urged applicants and DMF holders to consult the guidance appendix before submitting a prior assessment request and to ensure all required applicant and DMF-holder information is included so the agency can respond in a timely manner.
