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Avandia and the Commercial Impact of FDA's Credibility Gap

 
• By Ramsey Baghdadi

GlaxoSmithKline's diabetes drug Avandia survived a perilous FDA advisory committee review. The real question is whether the industry can survive the damage to FDA's credibility.

By Ramsey Baghdadi

For GlaxoSmithKline PLC, an FDA advisory committee recommendation that the diabetes drug rosiglitazone (Avandia) stay on the market is cause for celebration. There hasn’t been a lot of good news...

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US FDA Meeting Drought Ends … With A Vengeance

 
• By Michael McCaughan

The first 100 days of the Trump Administration were notable for an extraordinary decline in the number of public meetings hosted by the US Food and Drug Administration. But the schedule changed quickly.

EMA Says Digital Transformation A ‘Fundamental Shift’ In Meeting Regulatory Challenges

 
• By Eliza Slawther

Sponsors can expect faster evaluation processes for key medicines and greater support in mitigating medicines supply shortages this year as part of the European Medicines Agency’s digital transformation overhaul.

US FDA Makary’s Pharma CEO Tour Goes Against Transparency Rhetoric

 
• By Sarah Karlin-Smith

FDA Commissioner Martin Makary will give industry a new avenue for access and influence despite his and HHS Secretary Robert F. Kennedy Jr.’s claims that the pharma-FDA relationship is too cozy.

EU To Track Decentralized Clinical Trials In CTIS To Support Innovation

 
• By Vibha Sharma

Monitoring the use of decentralized elements in clinical trials is a priority for the European medicines regulatory network.

More from Pink Sheet

US FDA Meeting Drought Ends … With A Vengeance

 
• By Michael McCaughan

The first 100 days of the Trump Administration were notable for an extraordinary decline in the number of public meetings hosted by the US Food and Drug Administration. But the schedule changed quickly.

PBM Investigation, Enforcement Action ‘Critical Priorities’ At FTC, Chair Says

 
• By Cathy Kelly

The new FTC chair addressed concerns that staffing cuts will undermine the commission’s commitment to pharmacy benefit manager oversight.

Could EU Collective Procurement Counter US Most Favored Nation Policy?

 
• By Francesca Bruce

Joint procurement, if used by member states to respond to potential pricing and access challenges caused by a US most favored nations pricing policy, would cause more uncertainty for pharmaceutical companies, warn industry representatives.