miércoles, 13 de abril de 2016

Abbreviated New Drug Application (ANDA): Generics > Office of Generic Drugs (OGD) Annual Report for 2015

Abbreviated New Drug Application (ANDA): Generics > Office of Generic Drugs (OGD) Annual Report for 2015

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Today, the Food and Drug Administration Office of Generic Drugs (OGD) posted their first Annual Report, for calendar year 2015.  2015 marked the highest number of generic drug approvals and tentative approvals ever awarded by OGD–more than 700. These generic drug products have the potential to provide more affordable care to thousands of patients with serious and life-threatening diseases.
OGD continues to improve our review infrastructure, meet all Generic Drug User Fee Amendments (GDUFA) commitments and promote consistency across all applications and applicants.

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