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The only technical publication dedicated to readers who formulate, manufacture, or package solid dosage forms.

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  • April 19, 2019

ROCKVILLE, MD—The Office of Generic Drugs (OGD) published its Annual Report for 2018, the first year the Generic Drug User Fee Amendments Reauthorization (GDUFA II) was in effect. During the year, the agency successfully implemented many of the provisions in GDUFA II and the FDA Reauthorization Act of 2017 (FDARA). These provisions included requests for pre-ANDA meetings, reconsideration requests, one-time marketing status updates to the “Orange Book,” and competitive generic therapy designation and exclusivity requests. The FDA also approved or tentatively approved 1,021 Abbreviated New Drug Applications (ANDAs) and published more than 250 new or revised guidances, product-specific guidances (PSGs), and manuals of policies and procedures (MAPP) for stakeholders. The full report can be accessed at www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/GenericDrugs/ucm631710.htm.