CDER SBIA Update: GDUFA Regulatory Science Initiatives Public Meeting

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The Information Source for Regulated Domestic and International Small Pharmaceutical Business and Industry

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FDA’s GDUFA Regulatory Science Initiatives Public Meeting

FDA is hosting The Generic Drug User Fee Amendments of 2012; Regulatory Science Initiatives Part 15 Public Meeting to give an overview of the current status of the regulatory science initiatives for generic drugs and an opportunity for public input on the FY 2015 research priorities.

FDA wants your input as we develop an annual list of regulatory science initiatives specific to generic drugs. We will take the information from the public meeting into account in developing the fiscal year (FY) 2015 Regulatory Science Plan. 

The meeting will be held at FDA’s main campus in Silver Spring, MD, on May 16, 2014, from 9:00am-5:00pm and will be webcast for those who cannot attend in person.

Submit electronic or written requests to make oral presentations and comments by April 25, 2014. Electronic or written comments will be accepted at any time until the docket closes on June 13, 2014. You may submit ideas on generic drug research topics that should be added to the FY 2015 Regulatory Science Plan by emailing GDUFARegulatoryScience@fda.hhs.gov.

If you wish to attend, either in person or via webcast, or present at the hearing, please email GDUFARegulatoryScience@fda.hhs.gov by April 25, 2014. 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 Thushi Amini (Thushi.Amini@fda.hhs.gov) by April 25, 2014. If you need special accommodations because of a disability, please contact Thushi Amini at least seven days before the hearing.