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US FDA Rethinking Post-Market Safety Function As Part Of New Drug Review 'Modernization'

 
• By Michael McCaughan

CDER Deputy Director Cavazzoni is leading the review, further indicating her status as heir-apparent to long-time drug center director Janet Woodcock. 

car racing in tunnel
How modern will OND look after the reorganization?

US FDA’s Center for Drug Evaluation & Research Deputy Director for Operations Patrizia Cavazzoni is overseeing a “ground up re-evaluation” of the agency’s approach to post-marketing drug safety as part of the broader reorganization of FDA’s new drug review program.

“We’re going to take a step back and look at how we regulate safety and safety reporting and analysis of...

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US FDA’s June Approval Forecast: Infection Prevention, Cancer And HAE

 
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EMA Touts Faster Global Post-Approval Changes Via Regulatory Reliance

 
• By Eliza Slawther

The European Medicines Agency says that a regulatory reliance pilot that it is supporting to speed up assessments of post-approval changes appears to be accelerating evaluation timelines in non-EU countries.

New EU Approvals

 
• By Neena Brizmohun

The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include two new products, one of which is Vyjuvek, Krystal Biotech's advanced therapy for treating dystrophic epidermolysis bullosa.

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UK MHRA: Bacteriophage Developers Wanted ‘More Clarity’ On UK Framework

 
• By Eliza Slawther

Julian Beach, interim executive director of healthcare quality and access at the UK drug regulator, the MHRA, tells the Pink Sheet how the agency is responding to increased efforts to develop bacteriophage therapies.

Respiratory Treatments Hit Hardest By HTA Terminations In England

 
• By Leela Barham

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New Era Begins In Korea: Policy Predictions For Biopharma

 
• By Jung Won Shin

As South Korea's new president immediately gets to work on setting initial policies, essential drug supplies, R&D incentives and AI-driven digital healthcare are among the key topics in focus.