FDA issues guidance regarding distribution of approved naloxone products
Sept 22 - Guidance helps advance public availability and access
Drugs
The Center for Drug Evaluation and Research (CDER) ensures that safe and effective drugs are available to improve the health of the people in the United States
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Recent News
CDER expert discusses first-year progress of Generic Drug Cluster
Sept 20 - Forum allows agencies to collaborate on regulatory drug topics
New drug treats adults with life-threatening kidney condition
Sept 15 - First FDA-approved medication for Type 1 hepatorenal syndrome
Upcoming Events
FDA to discuss CBER support of study data standards and submissions
New requirement for the Standard for the Exchange of Nonclinical Data
FDA to address drug development of products that contain nanomaterials
Event will highlight how a newly finalized guidance can be implemented
FDA Hosts Advisory Meeting on QMM program and KASA
Event to discuss future of QMM program and next stages of KASA
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