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Last updated about 17 hours ago
Activities Report of the Generic Drug Program (FY 2025) – FDARA Title VIII Sections 807 and 805
about 18 hours ago
Section 807 of the FDA Reauthorization Act of 2017 (FDARA) requires the...
Activities Report of the Generic Drug Program | FDARA Title VIII Sections 807 and 805
about 18 hours ago
Section 807 of the FDA Reauthorization Act of 2017 (FDARA) requires the...
Patient-Focused Drug Development Glossary
about 18 hours ago
This glossary defines terms that will be used in the series of...
Oncology (Cancer)/Hematologic Malignancies Approval Notifications
about 19 hours ago
FDA does not issue approval announcements for every approval or drug label...
FDA approves teclistamab in combination with daratumumab hyaluronidase-fihj for relapsed or refractory multiple myeloma
about 19 hours ago
On March 5, 2026, the Food and Drug Administration approved teclistamab (Tecvayli...
Premium Health Management Inc. dba Premium Health - 721474 - 02/20/2026
about 19 hours ago
Failure to Register and List/Misbranded
Safety Labeling Change Orders
about 23 hours ago
Section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act (FD&C Act)...
FDA to Address Unused Opioids in American Homes
about 24 hours ago
The U.S. Food and Drug Administration today issued a Request for Information...
FDA approves drug for pediatric patients with most common form of dwarfism
1 day ago
FDA approves drug for pediatric patients with most common form of dwarfism
GDUFA Type II API DMF Payment Receipts Report
1 day ago
GDUFA Type II API DMF Payment Receipts Report
Fiscal Year 2026 Generic Drug Science and Research Initiatives Public Workshop - 06/08/2026
1 day ago
This workshop provides an overview of the status of science and research...
Endothelin Receptor Antagonist REMS Information
1 day ago
FDA has determined that a REMS is no longer necessary to ensure...