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 Martha Nguyen |
GDUFA III Suitability Petitions | Rosanne Pagaduan Arlene Figueroa |
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 |
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 Zhen Zhang, PhD |
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 |
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 Andrei Perlloni Tom Ching |
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 Shabnam Foroughi, MD |
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
|
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 Jin Xu, PhD |
Facility Assessment for Pre-Marketing Applications
GDUFA-III Implementation - Facility Related Updates | Derek Smith, PhD Rakhi Shah, PhD |
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 Bayli Larson, PharmD |
Regulatory Reminders at the Finish Line | Vincent Sansone Rinku Patel |
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 |
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
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