Food and Drug Administration (FDA)
Center for Drug Evaluation and Research (CDER) Small Business Assistance Program
Generic Drug User Fee Amendment (GDUFA) and You Conference
June 12-13, 2013
WELCOME TO OUR FIRST GDUFA AND YOU CONFERENCE
Highlights of Day 1: Comprehensive overviews on:
- User Fees and Arrears List
- Drug Master Files (DMFs)
- Compliance Notes
- DUN and Bradstreet’s (D&B’s) Data Universal Numbering System (DUNS) Number
- Facility Establishment Identifiers (FEIs)
Highlights of Day 2: Explore in detail the technical aspects of:
- Electronic Submissions Gateway (ESG) and WebTrader
- Electronic Self-Identification
View the Agenda for more detailed information.
**NOTE ROOM BLOCK CUT OFF IS JUNE 7
Contracted rate and room availability cannot be guaranteed after June 7
- Advance registration is required.
- Registration is FREE and includes printed agenda. Presentation slides will be posted on FDA website approximately 2 weeks after conference ends.
- Complimentary WiFi/Internet will be available in the guest rooms, meeting area and hotel common areas.
- Session and conference evaluations will be made available via QR codes. Please download your preferred QR code reading application prior to the event.
- The meeting will NOT be webcast or taped.
- CONFERENCE REGISTRATION CLOSES ON JUNE 10.
*The attendee is responsible for accommodations, meals and hotel parking.
- June 12 and 13: Optional lunch networking session Persimmon Room, which is purchase on own.
- June 12 : Optional networking event in the Mica Lounge from 5pm-8pm which is purchase on own.