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U.S. FDA Generic Drug User Fee Amendments (GDUFA) Fees for 2013
The Generic Drug User Fee Amendments of 2012 (GDUFA) authorizes the U.S. Food and Drug Administration (FDA) to collect fees from certain companies identified in generic drug submissions, including...
View ArticleAll Required Drug Establishments must Self-Identify with FDA by December 3, 2012
Under the Generic Drug User Fee Amendments (GDUFA) of 2012, the Food and Drug Administration (FDA) is authorized to collect application fees for certain companies identified in generic drug...
View ArticleChanges in U.S. Medical Device Establishment Registration and Listings...
On August 2, 2012, the U.S. Food and Drug Administration (“FDA”) issued amended regulations for Medical Device Establishment Registration and Listing. These changes are required by the new U.S. Food...
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