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  4. Generic Drugs Forum (GDF) 2023: Celebrating 10 Years of the GDF - 04/12/2023
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Virtual | Virtual

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


Date:
April 12 - 13, 2023
Day1:
- ET
Day2:
- ET

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

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