FDA Panel Okays Purdue's Newer OxyContin, But Is Still Hung Up On Safety

FDA advisory committee members said a newer formulation of OxyContin may deter misuse, but its safety is unclear.

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

 

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.

EU CHMP Opinions And MAA Updates

 

This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.

HHS Rescinds COVID-19 Vaccine Advice, Usurping US CDC Role

 
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By stepping into the role of the Centers for Disease Control and Advisory Committee on Immunization Practices, HHS Secretary Robert F. Kennedy Jr. is causing further confusion and uncertainty about vaccine policy, experts say.