The Inevitable Outcome: Diabetes Safety Model Expands To Weight Loss…And Beyond?
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.
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FDA Drug Shortage Staff Gets Higher Profile As New Reporting Requirements Begin
The 11-member staff CDER devotes to drug shortages is moving to the Office of the Center Director and will report to Deputy Director for Regulatory Programs Doug Throckmorton.
Patient Advocacy 3.0: Outreach Stretches to First Stages of Regulatory Development
FDA is ready to bring patient voices and perspectives into the drug approval framework. Practically, that means that drug sponsors will have to develop new skills and structures for working with a familiar stakeholder group at an unfamiliar point in the drug development process. The new challenge was a major theme at PhRMA’s 2012 Annual Meeting.
CV Risk Assessment For All Obesity Drugs Seems Inevitable Pre-Approval Requirement
FDA’s Endocrinologic and Metabolic Drugs Advisory Committee March 29 voted 17-6 that all obesity drugs should be vetted for cardiovascular risk, but some could rely on a meta-analysis rather than an outcomes trial.