The cardiovascular outcomes standard used for diabetes drugs since 2008 is moving to weight loss. That is important in itself, but also for what it says about the lessons FDA has taken from the diabetes experience—and what it might mean about regulatory expectations for other chronic drug classes in the future.
Cardiologist William Hiatt (University of Colorado School of Medicine) has a problem with the Food & Drug Administration’s proposal to require cardiovascular outcomes studies for all weight loss drugs, even in the absence of a clear signal of CV risk.
“If you want to impose this requirement on a drug with no signals, I think you ought to impose it...
Legal experts warn, however, that new Mexican procurement rules are discriminatory and could be challenged in the courts.
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.
The Trump Administration’s rhetoric and policy approaches illustrate the confusion that often arises between efforts to cut drug prices and cutting spending.
