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Activity Outline
Generic Drugs Forum 2024: Regulatory Considerations to Enhance Generic Drug Access
April 10 - 11, 2024
The Bethesdan Hotel, Bethesda, MD and virtual
Generic Drugs Forum 2024: Regulatory Considerations to Enhance Generic Drug Access
April 10 - 11, 2024
The Bethesdan Hotel, Bethesda, MD and virtual
Activity Coordinators:
Forest Ford (Forest.Ford@fda.hhs.gov), Matthew Palumbo (Matthew.Palumbo@fda.hhs.gov), Brenda Stodart (Brenda.Stodart@fda.hhs.gov)
Description
The goal of the forum is to provide practical regulatory information to aid prospective applicants in submitting complete and high-quality applications to maximize the efficiency and utility of each assessment cycle. The intent is to reduce the number of assessment cycles and facilitate timely access to safe, effective, and high-quality generic medicines.
References
- Product-Specific Guidances for Generic Drug Development, https://www.accessdata.fda.gov/scripts/cder/psg/index.cfm
- Pharmaceutical Quality Resources, https://www.fda.gov/drugs/development-approval-process-drugs/pharmaceutical-quality-resources
- Industry Resources, https://www.fda.gov/drugs/generic-drugs/industry-resources
- Guidances Related to Generic Drugs (under topics, choose “generic drugs”), https://www.fda.gov/regulatory-information/search-fda-guidance-documents#guidancesearch
- Federal Register Notices Related to Generic Drugs, https://www.federalregister.gov/documents/search?conditions%5Bterm%5D=generic+drugs
- GDUFA Science and Research, https://www.fda.gov/drugs/generic-drugs/science-research
Learning Objectives
- Recognize and clarify essential regulatory information on how to engage with the FDA about ANDAs.
- Discuss and review how to improve the quality and reduce the review time for ANDAs.
- Identify and describe resources, best practices, common deficiencies, and opportunities to engage with the FDA from pre-ANDA to post-approval submissions.
Target Audience
This activity is intended for physicians, pharmacists, and nurses.
This activity is intended for physicians, pharmacists, and nurses.
Registration Information
Registration is complimentary; therefore refunds are not applicable. For information on how to register to attend this activity, please contact the Activity Coordinator(s) listed above.
Registration is complimentary; therefore refunds are not applicable. For information on how to register to attend this activity, please contact the Activity Coordinator(s) listed above.
Agenda
Day 1 April 10, 2024
Day 2 April 11, 2024
Day 1 April 10, 2024
| Time | Topic | Speaker |
|---|---|---|
| 8:45 - 9:05 AM EDT | Day One Admin Overview | Brenda Stodart, PharmD, MS, BCGP, RAC |
| 9:05 - 9:25 AM EDT | OGD Keynote | Iilun Murphy, MD |
| 9:25 - 9:45 AM EDT | OPQ Keynote | Susan Rosencrance, PhD |
| 9:45 - 10:15 AM EDT | Drug Shortages and Generic Drugs | Emily Thakur, R. Ph |
| 10:15 - 10:45 AM EDT | GDUFA III Policy Updates |
Tina Kiang, PhD Martha Nguyen, JD |
| 10:45 - 11:00 AM EDT | Break | |
| 11:00 - 11:20 AM EDT | GDUFA III Suitability Petitions |
Rosanne Pagaduan, PharmD Arlene Figueroa, JD |
| 11:20 - 11:40 AM EDT | Overview of the FDA's Product-Specific Guidance (PSG) Program | Joseph Kotsybar, PharmD |
| 11:40 - 12:00 PM EDT | Panel for Session One |
Emily Thakur, R. Ph Tina Kiang, PhD Rosanne Pagaduan, PharmD Arlene Figueroa, JD Joseph Kotsybar, PharmD Reynolds Cantave, PharmD |
| 12:00 - 1:00 PM EDT | Lunch | |
| 1:00 - 1:20 PM EDT | An Overview of Controlled Correspondence: GDUFA III Updates and a Comprehensive Analysis of Controlled Correspondences Received by the Office of Bioequivalence |
Marcia Fields, PharmD Zhen Zhang, PhD |
| 1:20 - 1:40 PM EDT | Overview of Quality Controlled Correspondence | Jennifer Anim, PharmD |
| 1:40 - 2:00 PM EDT | Overview and Considerations of Pre-ANDA Scientific Meetings Under GDUFA III | Maria Monroy-Osorio |
| 2:00 - 2:20 PM EDT | Unveiling the Data: Post-Complete Response Letter Scientific Meeting Requests under GDUFA III | Hiren Patel, PhD |
| 2:20 - 2:50 PM EDT | Panel for Session Two |
Marcia Fields, PharmD Zhen Zhang, PhD Jennifer Anim, PharmD Maria Monroy-Osorio Hiren Patel, PhD Karen Bengtson |
| 2:50 - 3:05 PM EDT | Break | |
| 3:05 - 3:25 PM EDT | ANDA Program Statistics | Edward Sherwood |
| 3:25 - 3:55 PM EDT | ANDA Project Management Topics: PLAIR and Cover Letter Attachments |
Andrew Kim, PharmD Andrei Perlloni Tom Ching, PharmD |
| 3:55 - 4:15 PM EDT | Quality ANDA Submission Best Practices and Communications | Steven Yang, PharmD |
| 4:15 - 4:45 PM EDT | Panel for Session Three |
Edward Sherwood Andrew Kim, PharmD Andrei Perlloni Tom Ching, PharmD Steven Yang, PharmD |
| 4:45 - 4:55 PM EDT | Day One Admin Closing | Brenda Stodart, PharmD, MS, BCGP, RAC |
| Time | Topic | Speaker |
|---|---|---|
| 8:30 - 8:40 AM EDT | Day Two Admin Overview | Brenda Stodart, PharmD, MS, BCGP, RAC |
| 8:40 - 9:00 AM EDT | Pediatric Excipient Evaluation: A BE Perspective | Yang Lu, PhD |
| 9:00 - 9:20 AM EDT | GDSA-BE: Modernizing Bioequivalence Assessment for Abbreviated New Drug Applications | Tao Bai, PhD |
| 9:20 - 9:50 AM EDT | Bio-IND Best Practices: An Analysis of Common Clinical Safety Hold and Non-Hold Issues and Comparative Analyses Update |
Andrea Dugas, MD, PhD Shabnam Foroughi, MD |
| 9:50 - 10:10 AM EDT | Successful Practices for Pharm/Tox Justification in ANDAs | Jimena Dancy, PhD |
| 10:10 - 10:40 AM EDT | Panel Session Four |
Yang Lu, PhD Tao Bai, PhD Andrea Dugas, MD, PhD Shabnam Foroughi, MD Jimena Dancy, PhD |
| 10:40 - 10:55 AM EDT | Break | |
| 10:55 - 11:15 AM EDT | Nitrosamine Risk Assessment in Type II DMFs Supporting GDUFA Applications | Govindaraj Kumaran, PhD |
| 11:15 - 11:35 AM EDT | Post Approval Changes in Complex Generics from Drug Product/CMC Perspectives | David Awotwe-Otoo, PhD |
| 11:35 - 11:55 AM EDT | Quality Considerations for Topical Ophthalmic Drug Products – Guidance for Industry | Asif Rasheed, PhD |
| 11:55 - 12:25 PM EDT | Panel for Session Five |
Govindaraj Kumaran, PhD David Awotwe-Otoo, PhD Asif Rasheed, PhD |
| 12:25 - 1:25 PM EDT | Lunch | |
| 1:25 - 1:45 PM EDT | ANDA Submissions: Risk-Based Extractable and Leachable Quality Information |
Kshitij Patkar, PhD Jin Xu, PhD |
| 1:45 - 2:05 PM EDT | Facility Assessment for Pre-Marketing Applications |
Derek Smith, PhD Rakhi Shah, PhD |
| 2:05 - 2:25 PM EDT | ETP and AMTDP: Which Advanced Manufacturing Program is right for me? | Elisa Nickum, PhD |
| 2:25 - 2:45 PM EDT | Panel for Session Six |
Kshitij Patkar, PhD Jin Xu, PhD Derek Smith, PhD Rakhi Shah, PhD Elisa Nickum, PhD |
| 2:45 - 3:00 PM EDT | Break | |
| 3:00 - 3:20 PM EDT | Improving the Sterility Assurance Application to the FDA | John Arigo, PhD |
| 3:20 - 3:40 PM EDT | The Bacterial Endotoxins Specification - Points to Consider | Erika Pfeiler, PhD |
| 3:40 - 4:00 PM EDT | General Overview of ANDAs Labeling Requirements for Rx to OTC Switched Products |
Sunny Pyon, PharmD Bayli Larson, PharmD |
| 4:00 - 4:20 PM EDT | Regulatory Reminders at the Finish Line |
Vincent Sansone, PharmD, CPH Rinku Patel, PharmD |
| 4:20 - 4:50 PM EDT | Panel for Session Seven |
John Arigo, PhD Erika Pfeiler, PhD Sunny Pyon, PharmD Bayli Larson, PharmD Vincent Sansone, PharmD, CPH Rinku Patel, PharmD |
| 4:50 - 4:55 PM EDT | Closing Remarks | Tawni Schwemer, CCMP |
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 13.25 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 13.25 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 JA0002895-0000-24-045-L99-P for 13.25 contact hour(s).
CNE
FDA Center for Drug Evaluation and Research designates this activity for 13.25 contact hour(s).
Requirements for Receiving CE Credit
All learners claiming credit must attest to their attendance and complete all required activity evaluation(s) in the FDA CE Portal (ceportal.fda.gov) within 14 days after an activity ends. Upon completion, learners may view/print statement of credit.
Attention NABP Pharmacists and Pharmacy Technicians: The FDA CE Team will report your credit to the National Association of Boards of Pharmacy (NABP) provided you add your NABP ID and date of birth to your profile in the FDA CE Portal. The only official Statement of Credit is the one you pull from CPE Monitor. If you do not see your credit reflected on CPE Monitor* after 45 days of attestation, please contact FDACETeam@fda.hhs.gov. *CPE Monitor sets a strict 60-day limit on uploading credits.
Disclosure
Faculty
Planning Committee
CE Consultation and Accreditation Team
Faculty
- Anim, Jennifer, PharmD, Pharmacologist, OPQ - nothing to disclose
- Arigo, John, PhD, Division Director, OPMA/DPMA2 - nothing to disclose
- Awotwe-Otoo, David, PhD, Senior Pharmaceutical Quality Assessor, DPQA III/OPQA I/OPQ/CDER - nothing to disclose
- 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
- Cantave, Reynolds, PharmD, Sr. Regulatory Health Project Manager, FDA/CDER/OPQ - nothing to disclose
- Ching, Tom, PharmD, Regulatory Project Manager, FDA - nothing to disclose
- Dancy, Jimena, PhD, Pharmacologist, DPTR/OSCE/OGD/CDER/FDA - nothing to disclose
- Dugas, Andrea, MD, PhD, Physician, FDA - nothing to disclose
- Fields, Marcia, PharmD, Pharmacist, United States Public Health Service - nothing to disclose
- Figueroa, Arlene, JD, Regulatory Counsel, Food and Drug Administration - nothing to disclose
- Foroughi, Shabnam, MD, Physician, OGD/CDER/FDA - nothing to disclose
- Kiang, Tina, PhD, Division Director, FDA - nothing to disclose
- Kim, Andrew, PharmD, Supervisory Project Manager, FDA - nothing to disclose
- Kotsybar, Joseph, PharmD, Regulatory Health Project Manager, FDA - Center for Drug Evaluation & Research - nothing to disclose
- Kumaran, Govindaraj, PhD, Chemist, FDA - nothing to disclose
- Larson, Bayli, PharmD, Pharmacist, FDA - nothing to disclose
- Lu, Yang, PhD, Senior Staff Fellow, CDER - nothing to disclose
- Monroy-Osorio, Maria, Regulatory Health Project Manager, FDA - nothing to disclose
- Murphy, Iilun, MD, Director, CDER/Office of Generic Drugs - nothing to disclose
- Nguyen, Martha, JD, Director, Division of Policy Development, Office of Generic Drug Policy - nothing to disclose
- Nickum, Elisa, PhD, Sr. Regulatory Health Project Manager, CDER - nothing to disclose
- Pagaduan, Rosanne, PharmD, Supervisory Pharmacist, US F.D.A. - nothing to disclose
- Patel, Hiren, PhD, Senior Staff Fellow, U.S. Food and Drug Administration - nothing to disclose
- Patel, Rinku, PharmD, Pharmacist, CDER - nothing to disclose
- Patkar, Kshitij, PhD, Senior Pharmaceutical Quality Assessor, FDA - nothing to disclose
- Perlloni, Andrei, Supervisory Consumer Safety Officer, FDA - nothing to disclose
- Pfeiler, Erika, PhD, Unit Supervisor, FDA/CDER/OPQ/OPMA - nothing to disclose
- Pyon, Sunny, PharmD, Pharmacist, FDA - nothing to disclose
- Rasheed, Asif, PhD, Pharmaceutical Quality Assessor, OPQA-II/OPQ/CDER/FDA - nothing to disclose
- Rosencrance, Susan, PhD, Director, FDA/CDER/OPQ/OLDP - nothing to disclose
- Sansone, Vincent, PharmD, CPH, director, FDA - nothing to disclose
- Schwemer, Tawni, CCMP, Associate Director for Regulatory Affairs, FDA/CDER/OGD - nothing to disclose
- Shah, Rakhi, PhD, Associate Director, FDA - nothing to disclose
- Sherwood, Edward, Director, Office of Regulatory Operations - nothing to disclose
- Smith, Derek, PhD, Deputy Director, CDER/OPQ/OPMA - nothing to disclose
- Stodart, Brenda, PharmD, MS, BCGP, RAC, Program Director, FDA - nothing to disclose
- Thakur, Emily, R. Ph, Team Leader, FDA/CDER/OCD/DSS - nothing to disclose
- Xu, Jin, PhD, Senior Pharmaceutical Quality Assessor, CDER/OPQ/OPQA II - nothing to disclose
- Yang, Steven, PharmD, RBPM, CDER/OPQ/OPRO - nothing to disclose
- Zhang, Zhen, PhD, Master Pharmacologist, FDA/CDER/OGD/OB/DBI - nothing to disclose
Planning Committee
- Dugas, Andrea, MD, PhD, Physician, FDA - 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.
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