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Latest posts
Last updated 42 minutes ago
7 Things to Know About How You Can Find CDER’s Drug Safety Information
about 1 hour ago
CDER’s role in providing timely, accessible, evidence-based information on a drug's safety...
FDA D.I.S.C.O. Burst Edition: FDA approval of Bizengri (zenocutuzumab-zbco) for Treatment of adults with advanced unresectable or metastatic pancreatic adenocarcinoma harboring a neuregulin 1 (NRG1) gene fusion with disease progression on or after prior s
about 2 hours ago
FDA D.I.S.C.O. Burst Edition: FDA approval of Bizengri (zenocutuzumab-zbco) for Treatment of...
FDA Roundup: December 27, 2024
3 days ago
The U.S. Food and Drug Administration is providing an at-a-glance summary of...
Compounding Research
3 days ago
FDA is engaged with the following institutions to conduct research to help...
Combined Food and Drug Administration and Sponsor Oncologic Drugs Advisory Committee Briefing Document
3 days ago
Combined Food and Drug Administration and Sponsor Oncologic Drugs Advisory Committee Briefing...
FDA approves nivolumab and hyaluronidase-nvhy for subcutaneous injection
3 days ago
FDA approves nivolumab and hyaluronidase-nvhy for subcutaneous injection
Drug Trials Snapshots - HYMPAVZI
3 days ago
HYMPAVZI is a drug used to prevent or reduce the frequency of...
Newly Added Guidance Documents
3 days ago
Guidance documents represent the FDA's current thinking on a particular subject. New...
Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices
3 days ago
Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices
M15 General Principles for Model-Informed Drug Development
3 days ago
M15 General Principles for Model-Informed Drug Development
E11A Pediatric Extrapolation
3 days ago
The purpose of this guideline is to provide recommendations for, and promote...