ECG Warehouse May Be Model For Critical Path FDA/Industry Partnerships

FDA's "ECG warehouse" could be a prototype for cardiovascular safety collaborations between FDA and industry under the Critical Path initiative, Center for Drug Evaluation & Research Deputy Director Douglas Throckmorton said Oct. 11

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England’s NICE To ‘Explore’ Severity Modifier Changes As Cost-Effectiveness Threshold Branded ‘Ridiculous’

 

Health technology assessment body NICE said it has taken on feedback about the implications of allowing higher cost-effectiveness thresholds for some medicines after senior health economists offered diverging views on its methods.

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.

Peter Marks Resigns From US FDA, Warns Kennedy Does Not Want Truth On Vaccines

 

In his resignation letter, the CBER director said he was willing to work with HHS Secretary Robert F. Kennedy Jr. to address concerns about vaccine safety, but "it has become clear that truth and transparency are not desired by the secretary."