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, […]

Section 807 of the FDA Reauthorization Act of 2017 (FDARA) requires the FDA to report on certain abbreviated new drug applications (ANDAs) subject to priority review […]

R. Angelo de Claro is a hematology-oncology physician and currently the Associate Director (Acting) for Global Clinical Sciences with the Oncology Center of Excellence. In this […]

[embedded content] Español Sun safety is always in season. It’s important to protect your skin from sun damage throughout the year, no matter the weather. Why? […]

[embedded content] Español When you go outdoors with your infant, whether for a quick stroll in the park or a day at the beach, it’s important […]

Expanded Access (Compassionate Use) Submission Data Archive: CDER and CBER CDRH Archived Data (2014-2018) CDRH IDE Expanded Access Requests (2014-2018)1 Expanded Access Totals FY 2014 FY […]

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, […]

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 […]

Expanded Access (Compassionate Use) Submission Data Archive: CDRH CDER and CBER Archived Data (2010-2018) CDER and CBER Tables FY 2010 – 2018 Graphs of Expanded Access […]