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Keeping Track: Submissions Galore, And Still More 'Breakthroughs'

 
• By Bridget Silverman

The latest drug development news and highlights from our FDA Performance Tracker.

The pipeline of products under review at FDA refilled in the past week after FDA's July 24 approvals jamboree, with submissions for products ranging from Merck & Co. Inc.'s problem-plagued anesthesia reversal agent to novel biologics for bleeding and immune disorders to new formulations of ADHD medications and the opioid overdose treatment naloxone.

FDA also continued issuing "breakthrough" therapy designations at a steady pace, with recently announced designations including a radiotherapeutic for rare...

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EU Sees Unified Pathway For Drug/IVD Studies As Key To Future Research Investment

 
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Woodcock: Do Not Do The Wrong Study, Even If Against US FDA Advice

 
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UK Looks To Auto-Match NHS Patients With Clinical Trials To Boost Recruitment

 
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More from R&D

Woodcock: Do Not Do The Wrong Study, Even If Against US FDA Advice

 
• By Sarah Karlin-Smith

The former CDER director said she tells sponsors not to conduct an FDA-recommended study design or randomized trial if it will not work.

AI Will Bolster, Not Squelch, Patient Voice In Clinical Research, US FDA Says

 
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UK Looks To Auto-Match NHS Patients With Clinical Trials To Boost Recruitment

 
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