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:
- Wed, Apr 12 8:00 a.m. - 05:30 p.m. ET
- Day2:
- Thu, Apr 13 8:00 a.m. - 04:55 p.m. ET
Topics & Presentations Day 1 |
Speakers |
---|---|
Generic Drugs Forum (GDF) 2023: Celebrating 10 Years of the GDF – Day 1 – Keynote and Session 1 |
|
Jacqueline Corrigan-Curay, JD, MD |
|
Office of Generic Drugs (OGD) 2023 Outlook and Opportunities.pdf |
Iilun Murphy, MD |
Office of Pharmaceutical Quality (OPQ) 2023 Outlook and Opportunities.pdf |
Sau (Larry) Lee, PhD |
Controlled Correspondence Program Updates under GDUFA III.pdf |
Marcia Fields, PharmD |
Submitting a Successful Controlled Correspondence for Quality-Related Questions.pdf |
Shanaz Read, PhD |
An Overview of the FDA Product-Specific Guidance (PSG) Program under GDUFA III.pdf |
Christine Le, PharmD, PMP |
Questions & Panel Discussion |
Shanaz Read, Christine Le, and Malik Imam Manina Singh, PharmD, RAC, PMP Peter Capella, PhD Xiaoming Xu, PhD Lei K. Zhang, PhD Dave Coppersmith, JD |
Generic Drugs Forum (GDF) 2023: Celebrating 10 Years of the GDF – Day 1 - Session 2 |
|
Savita Nigam, PhD |
|
Abbreviated New Drug Application (ANDA) Meeting Requests.pdf |
Tina T. Nhu, PharmD, Mc. PM, BSPharm |
GDUFA III Mid-Cycle Review Meetings and Enhanced Mid-Cycle Review Meetings.pdf |
April Braddy, PhD, RAC |
A New GDUFA III Meeting: Post-CRL (Complete Response Letter) Scientific Meeting.pdf |
Tao Bai, PhD |
Questions & Panel Discussion |
Savita Nigam, Tina Nhu, April Braddy, Tao Bai, and Karen Bengtson Parth Soni, PharmD, MBA, PMP Xuan-Mai “Mai” Nguyen, PharmD |
Generic Drugs Forum (GDF) 2023: Celebrating 10 Years of the GDF – Day 1 - Session 3 |
|
Edward “Ted” Sherwood Russell Storms, PhD |
|
Jayani Perera, PhD |
|
Daniel Obrzut, PhD |
|
Kumara Subramanian, PhD |
|
Jennifer Sarchet, MSHA, BSN, RN, Charles Kerns |
|
Questions & Panel Discussion |
Jayani Perera, Daniel Obrzut, Kumara Subramanian, Jennifer Sarchet, Charles Kerns, and Rakhi Shah, PhD Srinivas Behara, PhD |
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 |
Considerations for Application Pathway: 505(b)(2) or ANDA.pdf |
Dave Coppersmith, JD |
Truong Quach, PharmD |
|
The Global Generic Drug Supply Chain and Need for International Dialogue.pdf |
Sarah Ibrahim, PhD |
Djamila Harouaka, PhD |
|
Questions & Panel Discussion |
Sharon Coleman, David Coppersmith, Truong Quach, Djamila Harouaka, and Andrew Fine, PharmD, BCPS |
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
|
Chitra Mahadevan, PharmD, MS Craig Kiester, RPh, MS, RAC |
Hui Zheng, PhD |
|
Archana A. Manerikar PharmD, MS |
|
Vipra Kundoor, PhD |
|
Structured Submission and Review (Module 3).pdf
Standardizing Quality Submissions and Assessments: PQ/CMC and KASA.pdf
|
Gideon (Scott) Gordon, PhD Norman Schmuff, PhD |
Nimmy Mathews, PharmD, MS, BCSPC, |
|
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 |
|
Julie Neshiewat, PharmD, BCPS, CPH Oluwakemi O. Odesina, PharmD, BCPS, Kodilichi (Kodi) Echeozo, PharmD, BCPS, |
|
Overview of Major Quality Deficiencies and Approaches Available in GDUFA III.pdf |
Karen Ireland, MS, PMP, RAC-Drugs |
Drug Product Quality Tips: Drug-Device Combination Products.pdf |
Kai Kwok, PhD |
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 |
|
Keduo Qian, PhD |
|
Rajib Paul, PhD Bo Jiang, PhD |
|
Paul Schwartz, PhD Olugbenga (Gbenga) Okubadejo, PharmD |
|
Lane Cristensen, PhD Michael Chasey, MS |
|
Questions & Panel Discussion |
Keduo Qian, Rajib Paul, Bo Jiang, Paul Schwartz, Olugbenga (Gbenga) Okubadejo, Lane Christensen, Michael Chasey, and Derek Smith, PhD |
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 |
Seyoum Senay |
|
Impact Assessment of the 2021 Data Integrity Notifications to Sponsors.pdf |
Nilufer Tampal, PhD |
Pallavi Nithyanandan |
|
Approaches to Mitigate the Risk of Nitrosamine Impurities in Pharmaceuticals.pdf |
David Keire, PhD |
Questions & Panel Discussion |
Jonathan Resnick, Seyoum Senay, Nilufer Tampal, Pallavi Nithyanandan, David Keire, and Likan Liang, PhD |
Day Two Closing |
|
Visit CDER Small Business and Industry Assistance Page
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