Conference | Mixed

Event Title

Generic Drugs Forum (GDF) 2024: Regulatory Considerations to Enhance Generic Drug Access

April 10 - 11, 2024

Date:: April 10 - 11, 2024
Day1:: Wed, Apr 10 8:30 a.m. - 05:00 p.m. ET
Day2:: Thu, Apr 11 8:30 a.m. - 05:00 p.m. ET

Topics & Presentations Day 1	Speakers
Generic Drugs Forum (GDF) 2024: Regulatory Considerations to Enhance Generic Drug Access – Day One – Part One
Office of Generic Drugs (OGD) Keynote	Iilun Murphy, MD Director Office of Generic Drugs (OGD) \| CDER
Office of Pharmaceutical Quality (OPQ) Keynote	Susan Rosencrance, PhD Acting Deputy Director of Science Office of Pharmaceutical Quality (OPQ) \| CDER
Drug Shortages and Generic Drugs	CAPT Jouhayna Saliba, Pharm.D. Team Leader Drug Shortage Staff (DSS) CDER/Office of the Center Director
Generic Drugs Forum (GDF) 2024: Regulatory Considerations to Enhance Generic Drug Access – Day One – Part Two
GDUFA III Policy Updates	Tina Kiang Director Division of Regulations and Guidance (DRGS) Office of Policy for Pharmaceutical Quality (OPPQ) OPQ \| CDER Martha Nguyen Director Division of Policy Development (DPD) Office of Generic Drug Policy (OGDP) OGD \| CDER
GDUFA III Suitability Petitions	Rosanne Pagaduan Supervisory General Health Scientist Division of Filing Review (DFR) Office of Regulatory Operations (ORO) OGD \| CDER Arlene Figueroa Regulatory Counsel Division of Legal and Regulatory Support (DLRS) OGDP \| OGD \| CDER
Overview of the FDA's Product-Specific Guidance (PSG) Program	Joe Kotsybar, PharmD Regulatory Health Project Manager Office of Research and Standards (ORS) OGD \| CDER
Q&A Discussion Panel	Jouhayna Saliba, Tina Kiang, Martha Nguyen, Rosanne Pagaduan, Arlene Figueroa, Joe Kotsybar and Reynolds (Rey) Cantave, PharmD Senior Regulatory Health Project Manager Enterprise Project Management Staff Office of Quality Assurance (OQA) OPQ \| CDER
Generic Drugs Forum (GDF) 2024: Regulatory Considerations to Enhance Generic Drug Access – Day One – Part Three
An Overview of Controlled Correspondence: GDUFA III Updates and a Comprehensive Analysis of Controlled Correspondences Received by the Office of Bioequivalence	Marcia Fields LCDR \| USPHS Regulatory Officer ORO \| OGD \| CDER \| FDA Zhen Zhang, PhD Master Pharmacologist Division of Bioequivalence I (DB I) Office of Bioequivalence (OB) OGD \| CDER
Overview of Quality Controlled Correspondence	Jenn Anim Pharmacologist - Policy Lead Division of Internal Policy and Communication OPPQ \| OPQ \| CDER
Overview and Considerations of Pre-ANDA (Abbreviated New Drug Application) Scientific Meetings Under GDUFA III	Maria Monroy-Osorio Regulatory Health Project Manager ORS \| OGD \| CDER
Unveiling the Data: Post-Complete Response Letter Scientific Meeting Requests under GDUFA III	Hiren Patel, PhD Senior Staff Fellow DB II \| OB \| OGD \| CDER
Q&A Discussion Panel	Marcia Fields, Zhen Zhang, Jenn Anim, Maria Monroy-Osorio, Hiren Patel and Karen Bengtson Supervisory Regulatory Health Project Manager ORS \| OGD \| CDER
Generic Drugs Forum (GDF) 2024: Regulatory Considerations to Enhance Generic Drug Access – Day One – Part Four
ANDA Program Statistics	Edward (Ted) Sherwood Director ORO \| OGD \| CDER
ANDA Project Management Topics: Pre-Launch Activities Importation Requests (PLAIR) and Cover Letter Attachments	Andrew Kim CDR \| USPHS Supervisory Project Manager Division of Project Management (DPM) ORO \| OGD \| CDER Andrei Perlloni Branch Chief Imports Compliance Branch (ICB) Division of Global Drug Distribution and Policy (DGDDP) Office of Drug Security, Integrity, and Response (ODSIR) OC \| CDER Tom Ching Regulatory Project Manager DPM \|ORO \| OGD \| CDER
Quality ANDA Submission Best Practices and Communications	Steven Yang LCDR \| USPHS Regulatory Business Process Manager Division of Regulatory & Business Process Management IV (DRBPM IV) OPRO \| OPQ \| CDER
Q&A Discussion Panel	Edward (Ted) Sherwood, Andrew Kim, Andrei Perlloni, Tom Ching, Steven Yang

Topics & Presentations Day 2	Speakers
Generic Drugs Forum (GDF) 2024: Regulatory Considerations to Enhance Generic Drug Access – Day Two – Part One
Pediatric Excipient Evaluation: Bioequivalence (BE) Perspective	Yang Lu, PhD Senior Staff Fellow DB III \| OB \| OGD \| CDER
GDSA-BE: Modernizing Bioequivalence Assessment for Abbreviated New Drug Applications (ANDAs)	Tao Bai, PhD Senior Advisor Office of Bioequivalence Immediate Office (OBIO) OGD \| CDER
Bio-IND Best Practices: an Analysis of Common Clinical Safety Hold and Non-hold Issues and Comparative Analysis Update Part 2: Comparative Analyses Update	Andrea Dugas, MD, PhD Physician Division of Clinical Safety and Surveillance (DCSS) Office of Safety and Clinical Evaluation (OSCE) OGD \| CDER Shabnam Foroughi, MD Physician Division of Clinical Review (DCR) OSCE OGD \| CDER
Successful Practices for Pharmacology/Toxicology (Pharm/Tox) Justification in ANDAs	Jimena Dancy, PhD Pharmacologist Division of Pharmacology/Toxicology Review (DPTR) OSCE \| OGD \| CDER
Q&A Discussion Panel	Yang Lu, Tao Bai, Andrea Dugas, Shabnam Foroughi, Jimena Dancy
Generic Drugs Forum (GDF) 2024: Regulatory Considerations to Enhance Generic Drug Access – Day Two – Part Two
Nitrosamine Risk Assessment in Type II Drug Master Files (DMFs) Supporting GDUFA Applications	Govindaraj Kumaran, PhD Chemist Division of Product Quality Assessment XIX (DPQA XIX) Office of Product Quality Assessment III (OPQA III) OPQ \| CDER
Post approval changes in Complex Generics from Drug Product/Chemistry Manufacturing & Controls (CMC) Perspectives	David Awotwe-Otoo, PhD Senior Pharmaceutical Quality Assessor DPQA III \| OPQA I \| OPQ \| CDER
Quality Considerations for Topical Ophthalmic Drug Products - Guidance for Industry	Asif Rasheed, PhD Senior Review Chemist DPQA VIII \| OPQA II \| OPQ \| CDER
Q&A Discussion Panel	Govindaraj Kumaran, David Awotwe-Otoo, Asif Rasheed
Generic Drugs Forum (GDF) 2024: Regulatory Considerations to Enhance Generic Drug Access – Day Two – Part Three
ANDA Submissions: Risk-Based Extractable and Leachable Quality Information	Kshitij Patkar, PhD Senior Pharmaceutical Quality Assessor Division of Pharmaceutical Manufacturing Assessment I (DPMA I) Office of Pharmaceutical Manufacturing Assessment (OPMA) OPQ \| CDER Jin Xu, PhD Senior Pharmaceutical Quality Assessor DPQA IX \| OPQA II \| OPQ \| CDER
Facility Assessment for Pre-Marketing Applications GDUFA-III Implementation - Facility Related Updates	Derek Smith, PhD Deputy Director OPMA \| OPQ \| CDER Rakhi Shah, PhD Associate Director OPMA \| OPQ \| CDER
Emerging Technology Program (ETP) and Advanced Manufacturing Technologies Designation Program (AMTDP): Which Advanced Manufacturing Program is Right for Me?	Elisa Nickum, PhD, PMP Senior Regulatory Health Project Manager DRBPM IV \| OPRO \| OPQ \| CDER
Q&A Discussion Panel	Kshitij Patkar, Jin Xu, Derek Smith, Rakhi Shah, Elisa Nickum
Generic Drugs Forum (GDF) 2024: Regulatory Considerations to Enhance Generic Drug Access – Day Two – Part Four
Improving the Sterility Assurance Application to the FDA	John Arigo, PhD Division Director DPMA II OPMA \| OPQ \| CDER
The Bacterial Endotoxins Specification - Points to Consider	Erika Pfeiler, PhD Unit Supervisor DPMA VI \| OPMA \| OPQ \| CDER
General Overview of ANDAs Labeling Requirements for Rx to OTC Switched Products	Sunny Pyon Labeling Project Manager Division of Labeling Review (DLR) Office of Regulatory Operations (ORO) OGD \| CDER Bayli Larson, PharmD Pharmacist Patent and Exclusivity Team (PET) Division of Legal & Regulatory Support (DLRS) Office of Generic Drug Policy (OGDP) OGD \| CDER
Regulatory Reminders at the Finish Line	Vincent Sansone CAPT \| USPHS Director DPM ORO \| OGD \| CDER Rinku Patel Program Management DLRS \| OGDP \| OGD \| CDER
Questions & Panel Discussion	John Arigo, Erika Pfeiler, Sonny Pyon, Bayli Larson, Vincent Sansone, Rinku Patel
Closing Remarks	Tawni B. Schwemer Senior Advisor Office of Generic Drugs

Agenda

Keynote Speakers

Iilun Murphy, MD
Director
Office of Generic Drugs
Center for Drug Evaluation and Research (CDER) | FDA

Susan Rosencrance, PhD
Acting Deputy Director for Science
Office of Pharmaceutical Quality (OPQ)
Center for Drug Evaluation and Research (CDER) | FDA

ABOUT THIS EVENT

The Generic Drugs Forum is an annual, two-day event that offers attendees the opportunity to hear from FDA subject matter experts from every part of the pre-ANDA program and ANDA assessment program. 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, with the intent to reduce the number of assessment cycles and facilitate timely access to safe, effective, and high-quality generic medicines.

This year’s theme is Regulatory Considerations to Enhance Generic Drug Access, and our agenda will address essential regulatory information on how to engage with the Agency and gain information about ANDA development and ANDA assessment. Presentations will focus on resources, best practices, common deficiencies, and opportunities to engage with the Agency from pre-ANDA to post-approval submissions.

INTENDED AUDIENCE

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

Are involved in generic drug development
Are submitting or have submitted a generic drug application, amendment, or supplement

TOPICS COVERED

Controlled Correspondence
Pre-ANDA Submissions and Meetings
ANDA Submissions, Assessments, and Meetings
Post-Approval Submissions
Other Considerations

Agenda

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