GDUFA: 2 ½ years later Impact & Importance

Transcription

1 GDUFA: 2 ½ years later Impact & Importance Georgia Hizon Manager, Regulatory Publications Fresenius Kabi USA, LLC Disclaimer The views and opinions expressed in the following PowerPoint slides are those of the individual presenter and should not be attributed to Drug Information Association, Inc. ( DIA ), its directors, officers, employees, volunteers, members, chapters, councils, Special Interest Area Communities or affiliates, or any organization with which the presenter is employed or affiliated. These PowerPoint slides are the intellectual property of the individual presenter and are protected under the copyright laws of the United States of America and other countries. Used by permission. All rights reserved. Drug Information Association, DIA and DIA logo are registered trademarks or trademarks of Drug Information Association Inc. All other trademarks are the property of their respective owners. 1

2 Agenda GDUFA in 2012 Review Process Test Cases: ANDA & Prior Approval Supplement Lessons Learned Process/Culture Changes GDUFA in 2012 The industry wants to know how this GDUFA will impact them: cost, inspection, submissions, review timelines, etc. Mr. Panic Mr. Confusion 2

3 GDUFA in 2012 Reference: Review Process Pre-GDUFA Microbiology Chemistry Labeling Bioequivalence Compliance (Site) ANDA Applicant Under GDUFA Microbiology Chemistry Labeling Bioequivalence Compliance (Site) FDA Project Manager ANDA Applicant 3

4 Test Cases: ANDA Deficiencies Received Separate deficiency letters Multiple deficiency letters About a year to respond Easily Correctable Deficiencies [ECD] with shorter timelines With goal dates [Complete Response Letter {CRL} or approval] Test Cases: ANDA Acceptance Pre-GDUFA Type II DMFs can be filed a day before an ANDA filing No completeness assessment on Type II DMFs Under GDUFA Type II DMFs have to be submitted, reviewed and should have a satisfactory completeness assessment, and posted publicly in the FDA website [Type II Drug Master Files Available for Reference List 4

5 Test Cases: ANDA Application Status Pre-GDUFA Increasing trend on the average approval times Reference: Sciences and Regulatory Advisory Committee Meeting 2013 Under GDUFA 60% within 15 months from date of submission (year 3 cohort) 75% within 15 months from date of submission (year 4 cohort) 90% within 10 months from date of submission (year 5 cohort) Reference: Generic Drug User Fee Act Program Performance Goals and Procedures Test Cases: PAS Deficiencies Received Separate deficiency letters from corresponding reviewing discipline Multiple deficiency letters About a year to respond ECDs with shorter timelines With goal dates [CRL or approval] 5

6 Test Cases: PAS Submission Status Pre-GDUFA Varying approval times Under GDUFA 60% within 6 months [no inspection] or 10 months [with inspection] (year 3 cohort) 75% within 6 months [no inspection] or 10 months [with inspection] (year 4 cohort) 90% within 6 months [no inspection] or 10 months [with inspection] (year 5 cohort) E.g., PAS filed on 02/2015 & approved on 04/2015 = ~40 days turnaround Reference: Guidance for Industry: ANDA Submissions Prior Approval Supplements Under GDUFA 2014 Lessons Learned Pre-GDUFA Multiple deficiency letters received in sequential manner Complete submission = acceptance for filing No Type II DMF completeness assessment No goal date Typically 1 year to respond to deficiencies Approvals received in months or several years Post-GDUFA Streamlined review process with all minor comments as ECDs and all other comments under one CRL Complete submission + ECDs responded = acceptance for filing Type II DMF filed, satisfactory assessment, & publicly available With goal date and/or target action date ECD responses in a matter of days FDA review metrics 6

7 Process/Culture Changes ectd conversion a MUST Outlined timelines = predictable launches & implementations Submission processing efficiencies Solicited vs. unsolicited amendments Ask 7