Drugs

FDA’s GDUFA Public Hearing on Policy Development

[2-5-2015] FDA Reopens Comment Period for GDUFA Public Hearing on Policy Development

FDA has posted a Federal Register notice reopening the public docket to solicit comments on certain topics related to Generic Drug User Fee Amendments of 2012 (GDUFA) implementation and the GDUFA Commitment Letter that accompanies the legislation.

 
FDA will reopen the comment period to the public docket associated with the GDUFA Public Hearing on Policy Development for an additional 30 days. The public hearing was announced in the Aug. 19, 2014 Federal Register and held on Sept. 17, 2014 (FDA-2014-N-1168).
 
The agency has requested public input on the five draft guidance documents that were issued to facilitate implementation of GDUFA and on future policy priorities including recommendations for additional guidance topics to facilitate GDUFA implementation. FDA also requested feedback on issues that may arise in consideration of 180-day exclusivity provided for by paragraph IV patent certifications (section 505(j)(5)(b)(iv) of the FD&C Act). Finally, FDA requested feedback on the specific criteria FDA that should apply to identify an abbreviated new drug application (ANDA) as a first generic eligible for expedited ANDA review. FDA is no longer seeking comment on the first generic review prioritization category at this time. FDA will take the information presented at the public hearing and in comments to the docket into account when developing the fiscal year 2015 GDUFA priorities.
 
The Agency is reopening the docket in response to requests that FDA provide an additional opportunity to submit comments on these topics.
 
For more information and the latest events regarding GDUFA, please visit our Generic Drug User Fee Amendments of 2012 website.

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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FDA wants your input on the five draft guidance documents FDA has issued or will issue shortly to facilitate implementation of GDUFA.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.

Date

September 17, 2014

Time

9:00 a.m. to 5:00 p.m.

Location

College Park Marriott Hotel and Conference Center, 3501 University Blvd., East, Hyattsville, MD 20783, MD

Registration

Submit electronic or written requests to make oral presentations by September 3, 2014 and presentation materials are due by September 9, 2014, to GenericDrugPolicy@fda.hhs.gov. 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, please email GenericDrugPolicy@fda.hhs.gov. 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.

Contacts

For more information and the latest events regarding GDUFA, please visit our Generic Drug User Fee Amendments of 2012 website.

Sign Up for Email Alerts about GDUFA

 

Page Last Updated: 02/05/2015
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