ANDA review


OGD Extolls Review Enhancement at GRx+Biosims Meeting

At the AAM GRx+Biosims meeting last week in North Bethesda, Maryland, Ted Sherwood, Director of the Office of Regulatory Operations, Office of Generic Drugs, indicated that the negotiations for GDUFA III had led to a number of program enhancements in the generic drug review and approval processes.  He outlined a number of these changes from GDUFA II […]

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