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2013-05-16 FDA

2014财年仿制药厂商场地注册2013年5月31日到期

Please be aware that the fiscal year 2014 reporting period for self-identification is due by May 31, 2013.

GDUFA requires generic drug facilities, certain sites, and organizations identified in a generic drug submission to submit, update, or reconfirm identification information to FDA annually. If you are required to self-identify and have already done so for fiscal year 2014 then no further action is required. If you intend to self-identify, please do so as soon as possible.

Information including who is required to self-identify, how the information is submitted to FDA, the penalty for failure to self-identify, and the technical specifications are available on FDA’s GDUFA webpage.

FDA lists facilities that have successfully self-identified for fiscal year 2013 and fiscal year 2014 in a publicly available list, which is updated daily, at 1[1]

General questions should be sent to AskGDUFA@fda.hhs.gov. Technical questions related to submissions should be sent to CDEReFacility@fda.hhs.gov.

Please sign up on the GDUFA webpage to receive additional updates as they become available.

2013财年FDA场地注册已付费中国企业名单（141家）