miércoles, 4 de marzo de 2015

CDER SBIA Update: FDA’s GDUFA Regulatory Science Initiatives Public Meeting

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

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 2016 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) 2016 Regulatory Science Plan.
The meeting will be held at FDA’s main campus in Silver Spring, MD, on June 5, 2015, 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 May 15, 2015. Electronic or written comments will be accepted at any time until the docket closes on June 26, 2015. You may submit ideas on generic drug research topics that should be added to the FY 2016 Regulatory Science Plan by emailingGDUFARegulatoryScience@fda.hhs.gov.
If you wish to attend, either in person or via webcast, or present at the hearing, please emailGDUFARegulatoryScience@fda.hhs.gov by May 15, 2015. 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 May 15, 2015. If you need special accommodations because of a disability, please contact Thushi Amini at least seven days before the hearing.

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 SBIA survey: https://www.surveymonkey.com/s/CDERSBIA_Evaluation

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