lunes, 18 de agosto de 2014

CDER SBIA Update: FDA’s GDUFA Public Hearing on Policy Development

FDA/CDER's Small Business and Industry Assistance (CDER SBIA)

Please attend FDA’s GDUFA Public Hearing on Policy Development

FDA is hosting the Generic Drug User Fee Amendments of 2012; Public Hearing on Policy Development to solicit public comment on certain topics related to implementation of GDUFA and the GDUFA Commitment Letter that accompanies the legislation.
FDA wants your input on the five draft guidance documents FDA has issued or will issue shortly to facilitate implementation of GDUFA.  FDA also seeks your input on additional policy priorities under GDUFA, such as the Agency’s consideration of generic drug exclusivity and the category of first generics. We will take the information from the public meeting into account in developing the fiscal year 2015 GDUFA priorities.

The meeting will be held near FDA’s main campus at College Park Marriott Hotel and Conference Center, 3501 University Blvd., East, Hyattsville, MD 20783, MD, on September 17, 2014, from 9:00am-5:00pm

Submit electronic or written requests to make oral presentations by September 3, 2014 and presentation materials are due by September 9, 2014, to  Electronic or written comments will be accepted until October 13, 2014. You may submit ideas on GDUFA policy priorities and comments and view the Federal Register notice here.
If you wish to attend, either in person or via webcast, please email  We recommend that you register early, because seating is limited.  The email should contain complete contact information for each attendee (i.e., name, title, affiliation, address, email address, and telephone number). Those without email access can register by contacting Shaniece Bowens or Connie Wisner at 240-402-7923. If you need special accommodations because of a disability, please be in touch at least seven days before the meeting. 
For more information and the latest events regarding GDUFA, please visit our Generic Drug User Fee Amendments of 2012 website. We will post meeting materials as they become available here.
Federal Register Notice:

The Small Business and Industry Assistance program in the Center for Drug Evaluation and Research (CDER SBIA) provides guidance and information to regulated domestic and international small pharmaceutical business and industry through its website, email notifications, and workshops. This notification system provides current information from CDER/FDA via e-mail on a biweekly basis that is relevant to small pharmaceutical business, which includes Federal Register notices, guidances, workshop announcements, etc. This is an automated message delivery system. Replying to this message will not reach the CDER SBIA staff. If you have comments or questions, please contact us Monday through Friday 8:00AM - 4:30PM.
Please take our CDER Small Business survey:

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