User Fee Lists (Jan 27, 2023 17:18)
Fiscal Year (FY) 2017 GDUFA facility fees are due on October 3, 2016.

FDALabel: Full-Text Search of Drug Product Labeling (Jan 27, 2023 16:19)
FDALabel Database is a web-based application that allows users to perform customizable ...

Oncology (Cancer) / Hematologic Malignancies Approval Notifications (Jan 27, 2023 16:09)
Oncology (Cancer) / Hematologic Malignancies Approval Notifications

We Are Hiring (Jan 27, 2023 14:57)
FDA/CDER employment opportunities utilizing the FDA 21st Century Cures Act Hiring Autho...

Coronavirus Aid, Relief, and Economic Security Act (CARES Act) Drug Shortage Mitigation Efforts (Jan 27, 2023 14:13)
The Coronavirus Aid, Relief, and Economic Security Act (CARES Act) was signed into law ...

Competitive Generic Therapy Approvals (Jan 27, 2023 12:55)
A list of all FDA-approved abbreviated new drug applications for drug products that rec...

The Center for Research on Complex Generics (Jan 27, 2023 12:48)
FDA awards a 5-year grant to the University of Maryland and the University of Michigan ...

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