Generic Drugs Forum (GDF) 2026:
April 22-23, 2026
View Start Time on World Clock
This is a NO COST event
FDA Headquarters – White Oak, Maryland
or attend Virtually Online
The annual Generic Drugs Forum is a two-day event designed to facilitate the development and approval of safe, effective, and high-quality generic medicines. This premier event brings together FDA subject matter experts from every aspect of the pre-ANDA and ANDA assessment programs, offering unparalleled insights and guidance.
Attendees will gain practical regulatory knowledge to enhance their applications, streamline the assessment process, and reduce cycles. The forum’s primary goal is to support prospective and current applicants in submitting complete and high-quality submissions, ultimately ensuring timely access to affordable medications that benefit public health.
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Agenda & Speaker Bios
Event Agenda
The event agenda is still being refined and may be updated over time. The current version is v10, uploaded on April 15, 2026.
Speaker Biographies
The speaker biographies document provides detailed information for each of the event presenters.
In-Person Attendance Information
Venue
FDA White Oak Campus
10903 New Hampshire Ave, Building 31
The Great Room
Silver Spring, MD 20903
Transportation & Parking
Food & Drink
- Public meeting attendees may bring their own food and drink as campus access is restricted to the immediate meeting area.
- Restaurants near the FDA White Oak campus are available. Before leaving, meeting attendees should consider the amount of time needed to return to campus and go through security screening.
Recording Disclosure
This event will be recorded and made available to the public after its conclusion. Any information shared publicly by participants during the event will become part of that recording. This includes the verbal questions and answers sessions.
For Reasonable Accommodations
If special accommodations at the workshop are needed due to a disability, please email CDERSBIA@fda.hhs.gov at least 7 days in advance of the workshop date. Requests for sign language interpretation or Computer Aided Realtime Translation (CART)/captioning should be made 2 weeks in advance of the workshop and should be sent directly to the FDA Interpreting Services Staff email account: interpreting.services@oc.fda.gov.
Virtual Attendance: LOGIN
The above rooms will open ~15 minutes before each day begins.
If you encounter any technical issues, visit the Technical Issues Support Page
Files & Recordings
Download Presentation Slides
The links above will become active on the day before the event begins.
Session Evaluations
Day One:
Controlled Correspondences – Marcia Fields
Common Bioequivalence (BE) Study Design Deficiencies and How to Avoid Them – Zhen Zhang
Proactive Strategies to Avoid Major Filing Deficiencies and Other Filing Stumbling Blocks – Truong-Vinh Phung
An Update on CDER’s Quality Management Maturity (QMM) Program – Eric Twum
Using FDA’s Inactive Ingredient Database (IID): Best Practices and Considerations – Diana A Solana-Sodeinde
Standardized Principles Used to Determine Maximum Daily Dose – Melanie Mueller
Complex Drug Products – Quality Considerations for Generic Oligonucleotides – Likan Liang
Suitability Petitions – Karen Rothschild & Andrew Fine
Prioritization Requests – Bayli Larson & Andrew Kim
Addressing Patent and Exclusivity Requirements – Regulatory Reminders – Heather Strandberg
Orange Book: How Drug Product Listings are Added, Updated, and Maintained – Truong Quach
Overview of the FDA Product-Specific Guidance (PSG) Program – Joseph Kotsybar
Decoding PSGs for Complex Non-Oral Generics – Yan Wang
Product-Specific Guidances (PSGs) in Action – Myong-Jin Kim
Drug-Device Combination Products: A Quality Perspective – Sheela Rajesh
Day Two:
Factors that Can Facilitate Assessment of Type II Drug Master Files (DMFs) – Erin Skoda
Managing Your Letters of Authorization (LOAs) – Deborah Johnson
Regulatory Review Process for Type II Secondary DMFs – Madhusudhan Gowravaram
Pre-Abbreviated New Drug Application Meetings for Complex Drug Products: Do’s and Don’ts from the Quality Perspective – Sherry Bai
Common Microbiology Deficiencies for Ophthalmic Suspension Drug Products – Arlene Chen
Common Manufacturing Deficiencies for Complex Dosage Forms – Amit Kokate & Vicky He
Data Integrity in ANDA Applications – Ke Ren
Best Practices for Safety Assessment of Nitrosamines in Generic Drugs – Xin Fu
BE Recommendations for Bridging Formulations of Nitrosamine-Impacted Drug Products – Paramjeet Kaur & Min Guo
Updates on Nitrosamines/ Nitrosamine Mitigation Strategies for Pharmaceuticals – Yuanling Liang & Diaa Shakleya
Quality and Safety Assessment of Extractables/Leachables in Generic Drug Products – Jin Xu & Vincent Crowley
ICH M13A High-Risk vs. Low-Risk Case Studies – Bioequivalence (BE) Implications – Suman Dandamudi
Bioanalytical Bioanalysis of Endogenous Drugs Using Surrogate Matrix Approach in Abbreviated New Drug Applications – Yang Lu
Recent Trends in Pharmaceutical Freeze-Drying and Control Strategies Observations – Steve Rhieu
Manufacturing Deficiencies in Liquid Drug Products: The Top Ten Issues – Allison Aldridge
Event Evaluation & Certificate
Evaluation & Certificate of Attendance
Session Recordings
Recordings will be linked here as soon as they are available.
Questions & More Information
Continuing Education
Real-time attendance is required for the certificate of attendance which can be used in support of CEs for the following professional organizations.
Certificates are only available during the two weeks post-event (until May 7, 2026).
This event has been pre-approved by:
- RAPS as eligible for a maximum of 12 credits for a two-day event (appropriate to real-time attendance) towards a participant’s RAC recertification upon full completion.
- SOCRA who accepts documentation of candidate participation in continuing education programs for re-certification if the program is applicable to clinical research regulations, operations or management, or to the candidate’s clinical research therapeutic area.
- SQA as eligible for 1 non-GCP or non-GLP unit for every 1 hour of instructional time towards a participant’s RQAP re-registration.
- ACRP for continuing education in clinical research. ACRP will provide 1 ACRP contact hour for every 45-60 minutes of qualified material.
Questions?
Please refer the FAQs page on this website. If you are not able to find your answer there, please email us at info@sbiaevents.com.
If you have questions regarding the content of the event or other CDER-specific information, please:
- Visit the CDER SBIA website
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