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Activity Outline
A Deep Dive: GDUFA III Scientific Meetings
May 15, 2023
A Deep Dive: GDUFA III Scientific Meetings
May 15, 2023
Activity Coordinators:
Forest Ford (Forest.Ford@fda.hhs.gov), Brenda Stodart (Brenda.Stodart@fda.hhs.gov)
Description
This webinar is developed for the generic drug industry. The types of participants that will benefit from this webinar include consultants, regulatory affairs professionals, and contractors. These professionals should work in generic drug development. Goals of the webinar are for the attendees to learn the process of how to submit an Abbreviated New Drug Application (ANDA) and how to properly respond to ANDA assessments.
References
- Guidance For Industry: Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA (October 2022) https://www.fda.gov/regulatory-information/search-fda-guidance-documents/formal-meetings-between-fda-and-anda-applicants-complex-products-under-gdufa-guidance-industry
- Draft Guidance for Industry: Product-Specific Guidance Meetings Between FDA and ANDA Applicants Under GDUFA (February 2023) https://www.fda.gov/regulatory-information/search-fda-guidance-documents/product-specific-guidance-meetings-between-fda-and-anda-applicants-under-gdufa
- GDUFA III Reauthorization https://www.fda.gov/industry/generic-drug-user-fee-amendments/gdufa-iii-reauthorization
- GDUFA III Enhancement to the Pre-ANDA Program https://www.fda.gov/industry/generic-drug-user-fee-amendments/gdufa-iii-enhancements-pre-anda-program
- ANDA Assessment Program – GDUFA III Performance Goals and Program Enhancements https://www.fda.gov/industry/generic-drug-user-fee-amendments/anda-assessment-program-gdufa-iii-performance-goals-and-program-enhancements
- MAPP 5240.10: Classifying Approved New Drug Products and Drug-device Combination Products as Complex Products for Generic Drug Development Purposes (April 2022) https://lnks.gd/l/eyJhbGciOiJIUzI1NiJ9.eyJidWxsZXRpbl9saW5rX2lkIjoxMDEsInVyaSI6ImJwMjpjbGljayIsImJ1bGxldGluX2lkIjoiMjAyMjA0MTMuNTYzODMwNDEiLCJ1cmwiOiJodHRwczovL3d3dy5mZGEuZ292L21lZGlhLzE1NzY3NS9kb3dubG9hZD91dG1fbWVkaXVtPWVtYWlsJnV0bV9zb3VyY2U9Z292ZGVsaXZlcnkifQ.oa6YLkvIHeiSxWTQ5rrmO_eDdUZPBdLpBwwA5mezhLo/s/1257355954/br/129776013972-l
Learning Objectives
- Identify improved methods and features to enhance meeting productivity.
- Determine best practices for generic drug development.
- Explain the protocol for meeting requests and the approval process.
Target Audience
This activity is intended for physicians, pharmacists, and nurses.
This activity is intended for physicians, pharmacists, and nurses.
Agenda
Day 1 May 15, 2023
Day 1 May 15, 2023
| Time | Topic | Speaker |
|---|---|---|
| 1:00 - 1:10 PM EDT | Overview |
Brenda Stodart, PharmD, MS, BCGP, RAC Renu Lal, Pharm.D. Nora Lim, PharmD Forest Ford, PharmD, R. Ph |
| 1:10 - 1:25 PM EDT | Introduction to GDUFA III Meetings | Lei Zhang, PhD |
| 1:25 - 1:50 PM EDT | GDUFA III Redesigned Pre-Submission Meetings | Karen Bengtson |
| 1:50 - 2:15 PM EDT | GDUFA III Post-Complete Response Letter (Post-CRL) Scientific Meetings | Tao Bai, PhD |
| 2:15 - 2:30 PM EDT | Break | |
| 2:30 - 2:35 PM EDT | SBIA Announcement |
Brenda Stodart, PharmD, MS, BCGP, RAC Renu Lal, Pharm.D. Nora Lim, PharmD Forest Ford, PharmD, R. Ph |
| 2:35 - 3:00 PM EDT | GDUFA III Product-Specific Guidance (PSG) Teleconferences | Caliope Sarago, MHSA |
| 3:00 - 3:25 PM EDT | GDUFA III Product-Specific Guidance (PSG) Meetings | Hee Sun Chung, PhD |
| 3:25 - 4:25 PM EDT | Q&A and Panel Discussion |
Lei Zhang, PhD Karen Bengtson Tao Bai, PhD Caliope Sarago, MHSA Hee Sun Chung, PhD Robert Lionberger, PhD Pinaki Desai, PhD John Ibrahim, PharmD, BCPS Partha Roy, PhD David Coppersmith, JD |
| 4:25 - 4:30 PM EDT | Closing Remarks | Robert Lionberger, PhD |
Continuing Education Accreditation
In support of improving patient care, FDA Center for Drug Evaluation and Research is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC) to provide continuing education for the healthcare team.
This activity was planned by and for the healthcare team, and learners will receive 3.25 Interprofessional Continuing Education (IPCE) credit(s) for learning and change.
CME
FDA Center for Drug Evaluation and Research designates this live activity for a maximum of 3.25 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
CPE
This knowledge-based activity has been assigned ACPE Universal Activity Number JA0002895-0000-23-036-L99-P for 3.25 contact hour(s).
CNE
FDA Center for Drug Evaluation and Research designates this activity for 3.25 contact hour(s).
Requirements for Receiving CE Credit
Physicians, pharmacists, nurses, and those claiming non-physician CME: participants must attest to their attendance and complete the final activity evaluation via the CE Portal (ceportal.fda.gov). For multi-day activities, participants must attest to their attendance and complete the faculty evaluation each day. Final activity evaluations must be completed within two weeks after the activity - no exceptions.
Attention Pharmacists and Pharmacy Techs: Failure to provide your correct NABP AND Date of Birth information, in the required format, may result in the loss of credit for this activity. NABP profile number should be the 6-7 digit profile number assigned by the CPE Monitor and your birth date should be in the MMDD format (e.g. 0721) Do not provide your pharmacy license number. Please click the "My Account" tab and then navigate to "Edit Contact Information" to verify that your information is correct.
Important Note regarding completion of evaluations and receiving credit
Attendees have 14 days from the last day of the activity to log in, complete the required evaluation(s) and attest to your attendance to claim credit.Physicians and nurses may then view/print statement of credit. Pharmacists should log into the CPE monitor 8 weeks after the last session of the activity to obtain their CE credit.
Attendees have 14 days from the last day of the activity to log in, complete the required evaluation(s) and attest to your attendance to claim credit.Physicians and nurses may then view/print statement of credit. Pharmacists should log into the CPE monitor 8 weeks after the last session of the activity to obtain their CE credit.
Disclosure
Faculty
Planning Committee
CE Consultation and Accreditation Team
Faculty
- Bai, Tao, PhD, Senior Advisor, FDA - nothing to disclose
- Bengtson, Karen, Supervisory Regulatory Health Project Manager, U.S. Food and Drug Administration - nothing to disclose
- Chung, Hee Sun, PhD, Lead Pharmacologist, FDA/CDER/OGD/OB/DBI - nothing to disclose
- Coppersmith, David, JD, Regulatory Counsel, Office of Generic Drug Policy - nothing to disclose
- Desai, Pinaki, PhD, Chemist, FDA - nothing to disclose
- Ford, Forest, PharmD, R. Ph, CSO, FDA - nothing to disclose
- Ibrahim, John, PharmD, BCPS, Associate Director for Regulatory Affairs, FDA - nothing to disclose
- Lal, Renu, Pharm.D., Pharmacist, FDA - nothing to disclose
- Lim, Nora, PharmD, Pharmacist, FDA - nothing to disclose
- Lionberger, Robert, PhD, Director, Office of Research and Standards - nothing to disclose
- Roy, Partha, PhD, Director, Office of Bioequivalence, Office of Generic Drugs - nothing to disclose
- Sarago, Caliope, MHSA, Senior Regulatory Health Project Manager, FDA - nothing to disclose
- Stodart, Brenda, PharmD, MS, BCGP, RAC, Program Director, FDA - nothing to disclose
- Zhang, Lei, PhD, Deputy Director, Office of Research and Standards, Office of Generic Drugs, CDER, FDA - nothing to disclose
Planning Committee
- Luke, Markham, MD, PhD, Director, DTP, U.S. Food and Drug Administration - nothing to disclose
- Paraoan, Dianne, MPH, BSN, RN, Associate Director for Regulatory Affairs, FDA/ CDER/ OMP - nothing to disclose
- Stodart, Brenda, PharmD, MS, BCGP, RAC, Program Director, FDA - nothing to disclose
CE Consultation and Accreditation Team
- Henderson, Darlise, MBA, Training Specialist, FDA/CDER/OEP/DLOD - nothing to disclose
- Bryant, Traci, M.A.T., Lead Training Specialist, FDA/CDER/OEP/DLOD - nothing to disclose
- Wood, Sara, Accreditation Program Administrator, CECAT, FDA/CDER/OEP/DLOD - nothing to disclose
Any relationship shown above in italics has been divested within the last 24 months and is therefore considered mitigated.
All relevant financial relationships have been mitigated.
All relevant financial relationships have been mitigated.
Registration Information
Registration is complimentary; therefore refunds are not applicable.
Registration is complimentary; therefore refunds are not applicable.
Requirements for Certificate of Completion (Non CE)
Must attend 50% of the activity.
Must attend 50% of the activity.
U.S. Food and Drug Administration