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January 15, 2025

Drug Compliance Programs

FDA compliance programs provide guidance and instructions to FDA staff for obtaining information to help fulfill agency plans in the specified program area. These compliance programs […]
January 14, 2025

FDA Roundup: January 14, 2025

For Immediate Release: January 14, 2025 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the […]
January 14, 2025

Drug Trials Snapshot: ATTRUBY

HOW TO USE THIS SNAPSHOT The information provided in Snapshots highlights who participated in the key clinical trials that supported the original FDA approval of this […]
January 13, 2025

OCMO Guidance Agenda

The Office of the Chief Medical Officer (OCMO) is sharing the following lists of guidance documents for public review and input: Guidance documents we intend to […]
January 13, 2025

OCMO Guidance Documents

About OCMO Guidance Documents The Office of the Chief Medical Officer (OCMO) provides executive leadership, coordination, and oversight of FDA cross-cutting clinical and public health emergency-related […]
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