________________________________________________________________________ MEETING MINUTES ________________________________________________________________________ SUBJECT: FDA-GPhA Quarterly Meeting DATE: December 16, 2014 FDA ATTENDEES: Janet Woodcock - Center for Drug Evaluation and Research (CDER) Kathleen (“Cook”) Uhl - Office of Generic Drug (OGD) Mike Ahmadi – OGD Jessica Benjamin – OGD Mary Dempsey - OGD Dale Connor – OGD Keith Flanagan - OGD Leslie-Anne Furlong – OGD Thomas Hinchliffe – OGD Edward Kim – OGD Robert Lionberger – OGD Paula McKeever - OGD Martha Nguyen – OGD Linda Park – OGD John Peters – OGD Edward Sherwood – OGD Denise Toyer Mckan – OGD Trang Tran – OGD Jason Woo – OGD Grail Sipes - Office of Regulatory Policy (ORP) Sachin Shah – Office of Management Susan Rosencrance – Office of Pharmaceutical Science (OPS) Theresa Mullin– Office of Strategic Programs (OSP) Hilmar Hamann – OSP Russell Wesdyk – OSP Ellen Morrison – Office of Regulatory Affairs (ORA) Melinda Plaisier - ORA Ann Marie Montemurro – ORA David Burrow – Office of Compliance (OC) John Kadavil – OC Sean Kassim – OC Bill Taylor - OC Mary Beth Clarke – Office of Executive Programs (OEP) Virginia Behr - OEP ShaAvhree Buckman-Garner – Office of Translational Sciences (OTS) Susan McCune - OTS SPONSOR ATTENDEES: GPhA Attendees: Momenta Mylan Impax Craig Wheeler – President and Chair of the GPhA Board Marcie McClintic Coates – Vice President, Regulatory Policy, GPhA Board Member Marcy Macdonald – Vice President, Regulatory Affairs, GPhA Board Member Apotex Teva Perrigo Fresenius-Kabi Hospira Sandoz Heritage Ranbaxy Amneal Zydus Lupin Jeremy Desai – President Scott Tomsky – Vice President, Regulatory Affairs Rich Stec – Vice President, Regulatory Affairs Molly Rapp – Vice President, Regulatory Affairs Lisa Skeens – Corporate Vice President, Global Regulatory Affairs Nick Tantillo – Vice President, Regulatory Affairs Pablo Davila – Vice President, Regulatory Affairs Robert Femia – Vice President, Regulatory Affairs Candis Edwards – Vice President, Regulatory Affairs Prashant Desai – Vice President, Regulatory Affairs William McIntyre – Senior Vice President, Regulatory Affairs GPhA GPhA GPhA GPhA GPhA Ralph Neas David Gaugh Lisa Tan Gordon Johnston Mark Hendrickson Agenda (for reference): I) II) III) Introduction Communications Transparency GDUFA Hiring Update IV) Inspection Parity Update V) OSI (BE) Inspection Program VI) FY14 Update VII) Submission Quality Follow up VIII) Wrap-up and Next Steps All FDA FDA FDA FDA FDA GPHA All Topics Discussed/Action Items: 1. Communication Transparency was discussed to improve communications on ANDA submissions. OGD intends to take a sequenced approach to assigning target action dates to the pre-year 3 original submissions. (slides 3-9) GPHA supported the proposed approach and plans to conduct robust oversight of its execution. Action: OGD/GPhA will discuss the mechanics and timing of Paragraph III and IV approvals in detail at next quarterly meeting. 2. Sachin Shah provided an update on CDER hiring (slides 10-13) 3. Ann Marie Montemurro provided an update on ORA hiring. 4. Russell Wesdyk provided an overview on GDUFA inspection commitments and the facility surveillance selection rules (slides 15-26). Action: FDA to provide clarity on the criteria involved in the inspection site selection model and decision rules. Action: FDA to provide an update on the site selection model implementation at a future quarterly meeting (late 2015). Action: FDA to provide a Program Alignment Group progress update at future quarterly meeting (late 2015). Action: FDA to provide status update on progress towards GDUFA Inspection Parity Goals at future quarterly meeting. 5. John Kadavil and Sean Kassim presented details on the Bioequivalence/Bioavailability Inspection program. (slides 28-34) 6. Kathleen Uhl provided an overview of FY14 highlights on GDUFA implementation and actions as well as preliminary numbers on overall actions in first 2 months of FY15 (slides 35-39). Action: OGD and OPQ to provide a Quality Management System update at next quarterly meeting. Action: FDA to provide update on progress with time to approval on pre-GDUFA applications. 7. David Gaugh provided an update on submission quality improvement efforts and indicated that the working group will be preparing an updated document on progress and it should be ready for discussion in 6 months. FDA recommended applicants look at their issued CR deficiencies to identify common or reoccurring deficiencies to target improvement. Action: GPHA to discuss submission quality efforts at quarterly meeting mid-2015. 8. Wrap-up Action items/Topics for next meeting: FDA: • Provide clarity on the criteria involved in the inspection site selection model and decision rules • Provide status update on progress towards GDUFA inspection parity goals in late 2015 • Provide a Program Alignment Group progress update to group in late 2015 • OGD and OPQ to provide a Quality Management System update • Provide update on progress with time to approval on pre-GDUFA applications GPhA: • GPHA to discuss submission quality efforts at quarterly meeting mid-2015 Both • Discuss the mechanics and timing of Paragraph III and IV approvals. Following the meeting GPHA inquired with the following questions and FDA provided responses: 1. Will the end of Streamlined Hiring Authority make it more difficult to hire for the hard-tofill positions? No, the end of streamlined hire will not make it more difficult to hire for the hard to fill positions. In CDER, we have used this authority in a very limited way to help quickly get staff on board. 2. What other resources will FDA use to fill those positions? CDER has filled its positions by heavily focusing on our outreach efforts by using a variety of social media (LinkedIn, Twitter, GDUFA webpage), current employees as recruiters, and an onsite event. We have also utilized the Agency’s Direct Hire Authority where available. CC: Janet Woodcock, CDER David Gaugh, GPhA
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