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The purpose of this public workshop is to communicate how FDA’s Generic Drug User Fee Amendments (GDUFA) Science and Research Program outcomes guide and facilitate generic drug development, regulatory assessment, and approval. This workshop will focus on common issues seen in abbreviated new drug applications (ANDAs), GDUFA III updates, GDUFA science and research on complex products and scientific issues to product-specific guidance development, pre-ANDA, and ANDA meeting discussions, and examine various areas of innovative science and cutting-edge methodologies behind generic drug development.
The agenda is still being refined and may be updated over time. The current version is v5, uploaded on August 2, 2024.
Speaker Biographies
The speaker biographies document is under development and will be linked here when it is ready.
Venue
The Bethesdan Hotel
8120 Wisconsin Avenue, Bethesda, MD 20814
Phone: 301-652-2000
Book Your Room Before the Discount Ends on August 23, 2024
Room reservation deadline: August 23, 2024 (COB eastern time) or when the room block is full (whichever comes first.)
Hotel Information
You may reserve your guest room by calling The Bethesdan Hotel directly at (301) 652-2000 and ask to be added to the “FDA Advancing Generic Drug Development Workshop” room block, or use this link to reserve online. The room block will close on August 23, 2024, or when the block is full, so don’t delay, reserve your room now! You will be responsible for reserving and paying for your own room accommodation. Please be mindful of the hotel’s policy regarding cancellations and early checkout. Check-in: 3:00 p.m. Checkout: 12:00 p.m.
Transportation & Parking
Dining
Please view the hotel’s Dining page for information on the food choice in the hotel.
To expedite your lunch break, you can pre-order from nearby restaurants using these links:
Networking Opportunity
A networking opportunity is available for on-site attendees during the workshop. The networking event will be held in the Fialova Bar at the hotel. This is an optional self-pay event.
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.
The links below will become active on the day of the workshop.
Attendance is tracked for CE.
Ability to submit questions, but cannot pause or rewind
1,000 seats – Use Login Two if this room is full
Attendance is tracked for CE.
Ability to submit questions, Ability to pause or rewind
Unlimited Seating
Attendance IS NOT TRACKED for CE.
If you encounter issues with the above logins, us this link.
The above login rooms will open ~15 minutes before each day begins.
If you encounter any technical issues, visit the Technical Issues Support Page
The audio for the event will be provided through your computer speakers (there will NOT be a teleconference number to dial into).
Download Presentation Slides:
The links above will become active on the day before the event begins.
Session Recordings:
Recordings will be linked here as soon as they are available.
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 October 9, 2024).
This event has been pre-approved for:
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.
More Information
If you have questions regarding the content of the event or other CDER-specific information, please: