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.

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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.)

BOOK YOUR ROOM

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

• Onsite Hotel discounted attendee parking: $10.00/day (regular $27.00); $15.00 discounted overnight parking
• Other paid parking garages nearby:
• Colonial Parking Garage (459 ft. from hotel): 8200 Wisconsin Avenue, Bethesda, MD 20814
• Garage 35 – Woodmont (0.1 miles from hotel): 7730 Woodmont Avenue, Bethesda, MD 20814 – Entrances: Woodmont Ave. & Old Georgetown Rd.
• Garage 40 – Cordell-St. Elmo (0.3 miles from hotel): 4935 St. Elmo Avenue, Bethesda, MD 20814 – Entrances: St. Elmo Avenue and Cordell Avenue
• Medical Center metro station – the hotel is 1 mile from Walter Reed National Military Medical Center
• Complimentary hotel shuttle to Metro is available

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:

• Sala Thai Bethesda – 3 min (0.1 mile) walk, 4828 Cordell Ave, Bethesda, MD 20814
• Guapo’s Tex-Mex – 1 min (59 ft. ) walk, 8130 Wisconsin Ave, Bethesda, MD 20814
• Big Greek Cafe – 1 min (59 ft. ) walk, 4806 Rugby Ave, Bethesda, MD 20814
• Fialova Restaurant – Located in The Bethesdan Hotel

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.