Generic Drugs Forum (GDF) 2023: Celebrating 10 Years of the GDF April 12 - 13, 2023

Virtual | Virtual

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• Date: April 12 - 13, 2023
• Day1: Wed, Apr 12 8:00 AM - 5:30 PM ET
• Day2: Thu, Apr 13 8:00 AM - 4:55 PM ET

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Topics & Presentations Day 1	Speakers
Generic Drugs Forum (GDF) 2023: Celebrating 10 Years of the GDF – Day 1 – Keynote and Session 1
CDER Keynote.pdf	Jacqueline Corrigan-Curay, JD, MD Principal Deputy Center Director Office of the Center Director Center for Drug Evaluation & Research (CDER) | FDA
Office of Generic Drugs (OGD) 2023 Outlook and Opportunities.pdf	Iilun Murphy, MD Deputy Director, Clinical and Regulatory Affairs Office of Generic Drugs (OGD) CDER | FDA
Office of Pharmaceutical Quality (OPQ) 2023 Outlook and Opportunities.pdf	Sau (Larry) Lee, PhD Deputy Director of Science Office of Pharmaceutical Quality (OPQ) CDER | FDA
Controlled Correspondence Program Updates under GDUFA III.pdf	Marcia Fields, PharmD Lieutenant Commander, United States Public Health Service (USPHS) Office of Regulatory Operations (ORO) OGD | CDER | FDA
Submitting a Successful Controlled Correspondence for Quality-Related Questions.pdf	Shanaz Read, PhD Program Lead, Controlled Correspondence Team Division of Internal Policies and Programs (DIPAP) Office of Policy for Pharmaceutical Quality (OPPQ) OPQ | CDER | FDA
An Overview of the FDA Product-Specific Guidance (PSG) Program under GDUFA III.pdf	Christine Le, PharmD, PMP CDR, USPHS PSG Program Director Office of Research and Standards (ORS) OGD | CDER | FDA
Questions & Panel Discussion	Shanaz Read, Christine Le, and Malik Imam CDR, USPHS, Deputy Director ORO | OGD |CDER | FDA  Manina Singh, PharmD, RAC, PMP Deputy Director Division of Bioequivalence Process Management (DPBM) Office of Bioequivalence (OB) OGD |CDER | FDA  Peter Capella, PhD Director Division of Immediate and Modified Release Products II (DIMRP II) Office of Lifecycle Drug Products (OLDP) OPQ | CDER | FDA  Xiaoming Xu, PhD Director Division of Product Quality Research (DPQR) Office of Testing and Research (OTR) OPQ | CDER | FDA  Lei K. Zhang, PhD Deputy Director ORS | OGD | CDER | FDA  Dave Coppersmith, JD Regulatory Counsel Division of Policy Development (DPD) Office of Generic Drug Policy (OGDP) OGD | CDER | FDA
Generic Drugs Forum (GDF) 2023: Celebrating 10 Years of the GDF – Day 1 - Session 2
An Overview of Pre-ANDA meetings under GDUFA III.pdf	Savita Nigam, PhD Senior Project Manager Office of Research and Standards (ORS) OGD | CDER | FDA
Abbreviated New Drug Application (ANDA) Meeting Requests.pdf	Tina T. Nhu, PharmD, Mc. PM, BSPharm Commander, USPHS Team Leader, Regulatory Project Manager Division of Project Management (DPM) ORO | OGD | CDER | FDA
GDUFA III Mid-Cycle Review Meetings and Enhanced Mid-Cycle Review Meetings.pdf	April Braddy, PhD, RAC Director Division of Bioequivalence III (DBIII) OB | OGD | CDER | FDA
A New GDUFA III Meeting: Post-CRL (Complete Response Letter) Scientific Meeting.pdf	Tao Bai, PhD Senior Advisor OB | OGD | CDER | FDA
Questions & Panel Discussion	Savita Nigam, Tina Nhu, April Braddy, Tao Bai, and Karen Bengtson Supervisory Regulatory Health Project Manager Office of Regulatory Science (ORS) OGD | CDER | FDA Parth Soni, PharmD, MBA, PMP Regulatory Project Manager DPM | ORO | OGD | CDER | FDA Xuan-Mai “Mai” Nguyen, PharmD Regulatory Project Manager DPM | ORO | OGD | CDER | FDA
Generic Drugs Forum (GDF) 2023: Celebrating 10 Years of the GDF – Day 1 - Session 3
GDUFA III Metrics.pdf	Edward “Ted” Sherwood Director ORO | OGD | CDER | FDA Russell Storms, PhD Associate Director for Analytics ORO | OGD | CDER | FDA
GDUFA III Impact on DMF Assessment.pdf	Jayani Perera, PhD Senior Chemist Division of Lifecycle API (DLAPI) OPQ | CDER | FDA
Facility Related Updates in GDUFA III.pdf	Daniel Obrzut, PhD Branch Chief Division of Pharmaceutical Manufacturing Assessment I (DPMA I) Office of Pharmaceutical Manufacturing Assessment (OPMA) OPQ | CDER | FDA
Quality Considerations for Developing Complex Generics.pdf	Kumara Subramanian, PhD Senior Pharmaceutical Quality Assessor Division of Liquid-Based Drug Products I (DLBP I) OLDP | OPQ | CDER | FDA
Risk Evaluation and Mitigation Strategies (REMS) for Generic Drugs: Use of a Drug Master File (DMF) and REMS Modifications.pdf	Jennifer Sarchet, MSHA, BSN, RN, GWCPM REMS Coordinator Division of Clinical Safety and Surveillance (DCSS) Office of Safety and Clinical Evaluation (OSCE) OGD | CDER | FDA Charles Kerns REMS Coordinator Division of Clinical Safety and Surveillance (DCSS) Office of Safety and Clinical Evaluation (OSCE) OGD | CDER | FDA
Questions & Panel Discussion	Jayani Perera, Daniel Obrzut, Kumara Subramanian, Jennifer Sarchet, Charles Kerns, and Rakhi Shah, PhD Associate Director for Science and Communications OPMA | OPQ | CDER | FDA Srinivas Behara, PhD Chemist Division of Immediate and Modified Release Products III (DIMRP III) OLDP | OPQ | CDER | FDA
Generic Drugs Forum (GDF) 2023: Celebrating 10 Years of the GDF – Day 1 - Session 4
Overview of CREATES Act and Covered Product Authorizations.pdf	Sharon Coleman, JD Senior Regulatory Counsel Division of Regulatory Policy II (DRP II) ORP | CDER | FDA
Considerations for Application Pathway: 505(b)(2) or ANDA.pdf	Dave Coppersmith, JD Regulatory Counsel DPD | OGDP | OGD | CDER | FDA
Resources Available on the Orange Book Website.pdf	Truong Quach, PharmD Acting Team Lead Division of Orange Book Publication and Regulatory Assessment (DOBPRA) OGDP | OGD | CDER | FDA
The Global Generic Drug Supply Chain and Need for International Dialogue.pdf	Sarah Ibrahim, PhD Associate Director for Stakeholder and Global Engagement OGD | CDER | FDA
Quality Management Maturity.pdf	Djamila Harouaka, PhD Senior Scientific Advisor Office of Quality Surveillance (OQS) OPQ | CDER | FDA
Questions & Panel Discussion	Sharon Coleman, David Coppersmith, Truong Quach, Djamila Harouaka, and Andrew Fine, PharmD, BCPS Commander, USPHS Senior Advisor Division of Clinical Review (DCR) Office of Safety and Clinical Evaluation (OSCE) OGD | CDER | FDA
Day One Closing

 

Topics & Presentations Day 2	Speakers
Generic Drugs Forum (GDF) 2023: Celebrating 10 Years of the GDF – Day 2 - Session 1
Best Practices for Abbreviated New Drug Applications (ANDAs) in GDUFA III.pdf     Best Practices for Abbreviated New Drug Applications (ANDAs) in GDUFA III: Office of Pharmaceutical Quality Perspective.pdf	Chitra Mahadevan, PharmD, MS Commander, USPHS Director Division of Bioequivalence Process Management (DBPM) OB | OGD | CDER | FDA Craig Kiester, RPh, MS, RAC Captain, USPHS Division Director Division of Regulatory & Business Process Management III (DRBPMIII) Office of Program and Regulatory Operations (OPRO) OPQ | CDER | FDA
Submission of In Vitro Release Test (IVRT) Data and Information for Topical Drug Products under ANDAs (3) Products.pdf	Hui Zheng, PhD Pharmacologist Division of Bioequivalence I (DBI) OB | OGD | CDER | FDA
Submission of In Vitro Permeation Test (IVPT) Data and Information for Topical Drug Products under ANDAs.pdf	Archana A. Manerikar PharmD, MS Pharmacologist DBI |OB | OGD | CDER | FDA
Considerations for Alternative Bioequivalence (BE) In Vitro Study Information Submitted in Nasal Drug.pdf	Vipra Kundoor, PhD Pharmacologist DBI | OB | OGD | CDER | FDA
Structured Submission and Review (Module 3).pdf     Standardizing Quality Submissions and Assessments: PQ/CMC and KASA.pdf	Gideon (Scott) Gordon, PhD Senior Health Informatics Officer Data Standards Staff (DSS) Office of Strategic Programs (OSP) CDER | FDA Norman Schmuff, PhD Associate Director for Science OPMA | OPQ | CDER | FDA
Information to Include with Cover Letters.pdf	Nimmy Mathews, PharmD, MS, BCSPC, CPGP Lieutenant Commander, United States Public Health Service (USPHS) Regulatory Project Manager ORO | OGD | CDER | FDA
Questions & Panel Discussion	Chitra Mahadevan, Craig Kiester, Hui Zheng, Archana A. Manerikar, Vipra Kundoor, G. Scott Gordon, Norman Schmuff, Nimmy Mathews, and Malik Imam, Andrew Fine
Generic Drugs Forum (GDF) 2023: Celebrating 10 Years of the GDF – Day 2 - Session 2
GDUFA III Labeling Updates and Tips.pdf	Julie Neshiewat, PharmD, BCPS, CPH Supervisor Division of Labeling Review (DLR) ORO | OGD | CDER | FDA Oluwakemi O. Odesina, PharmD, BCPS, CPH Labeling Reviewer DLR | ORO | OGD | CDER | FDA Kodilichi (Kodi) Echeozo, PharmD, BCPS, CPH Labeling Reviewer DLR | ORO | OGD | CDER | FDA
Overview of Major Quality Deficiencies and Approaches Available in GDUFA III.pdf	Karen Ireland, MS, PMP, RAC-Drugs Senior Regulatory Health Project Manager Division of Regulatory Business Process Manager II (DRBPMII) OPRO | OPQ | CDER | FDA
Drug Product Quality Tips: Drug-Device Combination Products.pdf	Kai Kwok, PhD Senior Pharmaceutical Quality Assessor Division of Liquid-Based Drug Products II (DLBP II) OLDP | OPQ | CDER | FDA
Questions & Panel Discussion	Julie Neshiewat, Oluwakemi "Kemi" Odesina, Kodilichi (Kodi) Echeozo, Karen Ireland, Kai Kwok
Generic Drugs Forum (GDF) 2023: Celebrating 10 Years of the GDF – Day 2 - Session 3
Change in API Supplier: Drug Substance Quality Tips.pdf	Keduo Qian, PhD Chemist Division of Lifecycle API (DLAPI) Office of New Drug Products (ONDP) OPQ | CDER | FDA
Change in API Supplier: Drug Product Quality Tips.pdf	Rajib Paul, PhD Senior Pharmaceutical Quality Assessor Division of Post marketing Assessment II (DPMA II) OLDP | OPQ | CDER | FDA Bo Jiang, PhD Senior Pharmaceutical Quality Assessor Division of Pharmaceutical Manufacturing Assessment I (DPMA I) OPMA | OPQ | CDER | FDA
Managing Quality Post-Approval.pdf	Paul Schwartz, PhD Director Division of Post marketing Assessment II (DPMA II) OLDP | OPQ | CDER | FDA Olugbenga (Gbenga) Okubadejo, PharmD Director Division of Regulatory & Business Process Management III (DRBPMIII) OPRO | OPQ | CDER | FDA
Inspection Tips: Best Practices for Remote Interactive Evaluations and Other Alternative Inspection Approaches.pdf	Lane Cristensen, PhD Branch Chief Division of Pharmaceutical Manufacturing Assessment IV (DPMA IV) OPMA | OPQ | CDER | FDA Michael Chasey, MS Supervisory Consumer Safety Officer Division of Pharmaceutical Quality Programs (DPQP) Office of Pharmaceutical Quality Operations (OPQO) Office of Medical Products and Tobacco Operations (OMPTO) Office of Regulatory Affairs (ORA) | FDA
Questions & Panel Discussion	Keduo Qian, Rajib Paul, Bo Jiang, Paul Schwartz, Olugbenga (Gbenga) Okubadejo, Lane Christensen, Michael Chasey, and Derek Smith, PhD Deputy Director Division of Pharmaceutical Manufacturing Assessment IV (DPMA IV) OPMA | OPQ | CDER | FDA
Generic Drugs Forum (GDF) 2023: Celebrating 10 Years of the GDF – Day 2 - Session 4
Submitting in eCTD: Most Common submission issues and FDA plans for eCTD v4.0.pdf	Jonathan Resnick Project Management Officer Office of Business Informatics (OBI) CDER | FDA
CDER NextGen Portal: What's New.pdf	Seyoum Senay Supervisory Operations Research OBI | CDER | FDA
Impact Assessment of the 2021 Data Integrity Notifications to Sponsors.pdf	Nilufer Tampal, PhD Associate Director for Scientific Quality OB | OGD | CDER | FDA
Risk Factors for Benzene Contamination.pdf	Pallavi Nithyanandan Director Compendial Operations and Standards Staff (COSS) OPPQ | OPQ | CDER | FDA
Approaches to Mitigate the Risk of Nitrosamine Impurities in Pharmaceuticals.pdf	David Keire, PhD Director Office of Testing and Research (OTR) OPQ | CDER | FDA
Questions & Panel Discussion	Jonathan Resnick, Seyoum Senay, Nilufer Tampal, Pallavi Nithyanandan, David Keire, and Likan Liang, PhD Branch Chief Division of Liquid-Based Drug Products II (DLBP II) OLDP | OPQ | CDER | FDA
Day Two Closing

 

Agenda

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ABOUT THIS MEETING

The Generic Drugs Forum (GDF) is an annual, two-day virtual event that offers attendees the opportunity to hear from FDA subject matter experts from every part of the generic drug assessment program. The goal of the forum is to provide information to aid potential and current applicants by offering practical advice and taking a deep dive into the Abbreviated New Drug Application (ANDA) assessment process.

This year’s theme is Celebrating 10 Years of GDF and presentations will focus on hot topics such as GDUFA III updates, information and technology, and complex generics.

TOPICS COVERED

• Generic Drug User Fee Amendments (GDUFA) through September 2027 (GDUFA III)
• Product Specific Guidances
• ANDA Submissions – Best Practices and Tips
• Policy, Global & Complex Generics Updates
• Information Technology Updates
• Using Orange Book as a Resource

KEYNOTE SPEAKERS

Jacqueline Corrigan-Curay, J.D., M.D
Principal Deputy Center Director
Center For Drug Evaluation and Research (CDER) | FDA

Iilun Murphy, M.D.
Deputy Director for Clinical and Regulatory Affairs
Office of Generic Drugs (OGD) | CDER | FDA

Sau (Larry) Lee, Ph.D.
Deputy Director of Science
Office of Pharmaceutical Quality (OPQ) | CDER | FDA

INTENDED AUDIENCE

The generic drug industry, consultants, regulatory affairs professionals, or contractors with an emphasis on those who:

• plan to submit an ANDA, are in the process of submitting an ANDA, or have submitted an ANDA
• are involved in generic drug development

FDA RESOURCES

• Product-Specific Guidances for Generic Drug Development
• Pharmaceutical Quality Resources
• Industry Resources
• Guidances Related to Generic Drugs (under topics, choose “generic drugs”)
• Federal Register Notices Related to Generic Drugs
• GDUFA Science and Research
• Approved Drug Products with Therapeutic Equivalence Evaluations | Orange Book