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February 16, 2024

CDER Small Business and Industry Assistance (SBIA) Learn

Generic Drugs Forum (GDF) 2024: Regulatory Considerations to Enhance Generic Drug Access Conference/Workshop 4/10/2024 ANDA, Bioequivalence, Chemistry Manufacturing and Controls (CMC), Controlled Correspondence, Generic Drug Development, […]
February 16, 2024

FDA Roundup: February 16, 2024

For Immediate Release: February 16, 2024 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:  On Thursday, […]
February 16, 2024

Drug Trials Snapshots: AGAMREE

HOW TO USE THIS SNAPSHOTThe information provided in Snapshots highlights who participated in the key clinical trials that supported the original FDA approval of this drug, […]
February 16, 2024

Data Standards Program Strategic Plan and Board

Strategic Plan CDER’s approach to data standards consists of four strategic goals: Support open, consensus-based data standards development Maintain and promote a well-defined data standards governance […]
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