Generic Drug Facilities, Sites and Organization Lists
Mon Aug 31 4:21 pm
FDA What's New: Drugs
Drug Alerts and Statements
Mon Aug 31 1:49 pm
See updates from CDER on fast-moving issues and learn about CDER's work to enhance public health
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What's New Related to Drugs
Mon Aug 31 1:14 pm
Want to know what's new on drugs from FDA? This page provides quick links to the latest on a variety of topics including: drug approvals, safety warnings, drug shortages, etc.
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International Collaboration to Advance New Testing Methods That Reduce Reliance on Horseshoe Crab Blood
Mon Aug 31 1:04 pm
FDA, working with international regulatory partners through the International Coalition of Medicines Regulatory Authorities (ICMRA), has completed a collaborative assessment of a new testing approach for biological products that could reduce reliance on horseshoe crab blood.
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Medical Countermeasure Monitoring and Assessment
Mon Aug 31 11:35 am
FDA guidance and regulatory information, specific FDA projects related to monitoring and assessment of MCMs, ongoing FDA work related to medical product assessment in general, and key efforts relevant to MCM monitoring and assessment outside of FDA
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Ana Salazar Modela Tu Cuerpo Inc. Issues Nationwide Voluntary Recall of Lipofit Extreme Fat Burner 2.0 Due to Presence of Undeclared Fluoxetine and 2,4-Dinitrophenol (DNP)
Mon Aug 31 10:54 am
FOR IMMEDIATE RELEASE - August 27, 2026 - Davie, Florida – Ana Salazar Modela Tu Cuerpo Inc. is recalling Lipofit Extreme Fat Burner 2.0, Lot 25M12F, expiration date 09/2027, to the consumer level. The Food and Drug Administration (FDA) laboratory analysis has found Lipofit Extreme Fat Burner 2.0 to
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Rare Disease Drug Approvals
Mon Aug 31 10:31 am
This page describes recent rare disease drug approvals that received a CDER or FDA communication. This is not an exhaustive list of all rare disease drug approvals.
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Rare Disease News & Events
Mon Aug 31 9:08 am
Drugs@FDA Data Files
Mon Aug 31 8:30 am
Drugs@FDA Downloadable Data File in ZIP format, Data Definitions, and Entity Relationship Diagram (ERD)
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Notable Approvals | Drugs
Mon Aug 31 8:14 am
FDA Approves Treatment for Essential Thrombocythemia
Mon Aug 31 8:12 am
The U.S. Food and Drug Administration has approved Besremi (ropeginterferon alfa-2b-njft) injection for the treatment of adults with essential thrombocythemia.
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B. Braun Medical Inc. Issues Voluntary Nationwide Recall of 0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB® Container Due to the Presence of Particulate Matter
Sat Aug 29 4:33 pm
FOR IMMEDIATE RELEASE – August 19, 2026– Bethlehem, PA, B. Braun Medical Inc (B. Braun) is voluntarily recalling three (3) lots of 0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB® Container, to the hospital/healthcare facility/user level due to presence of particulate matter identified a
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