Today, the Food and Drug Administration Office of Generic Drugs (OGD) posted their Annual Report for calendar year 2016. 2016 marked the highest number of generic drug approvals and tentative approvals ever awarded by OGD–more than 800. 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.
Direct link to the report: https://www.fda.gov/Drugs/
Office of Generic Drugs (OGD) Annual Report for 2016
Ensuring Safe, Effective, and Affordable Medicines for the American Public
We Welcome Your Feedback
OGD welcomes feedback from stakeholders and the public.
We will continue to communicate with industry as
we work to meet GDUFA goals.
we work to meet GDUFA goals.
Office of Generic Drugs
Center for Drug Evaluation and Research
U.S. Food and Drug Administration
10903 New Hampshire Avenue, Building 75
Silver Spring, Maryland 20993
GenericDrugs@fda.hhs.gov (240) 402-7920
Center for Drug Evaluation and Research
U.S. Food and Drug Administration
10903 New Hampshire Avenue, Building 75
Silver Spring, Maryland 20993
GenericDrugs@fda.hhs.gov (240) 402-7920
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