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Cole Werble

Washington, DC
Cole Werble is the former owner and editorial director of FDC Reports, Inc., the publisher of The Pink Sheet, The Gray Sheet, and other leading news publications for the health care industry. He has more than 35 years of experience analyzing business critical developments affecting the biopharma sector and developing world class information products for the sector.
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Latest From Cole Werble

FDA’s Sentinel Strategy: Starting Slow Move Toward “Active” Surveillance

US FDA’s strategic plan for Sentinel includes pilot projects to move towards the vision of active surveillance. However, FDA is also making clear that it won’t be a quick or easy transformation. 
Drug Safety Post Market Regulation & Studies

Civica Rx's Strategy To Reduce Drug Shortages Focuses On Guaranteed-Price Contracts

Non-profit intermediary being built by hospitals and health systems offers a private sector response to one of the deterrents to adequate supplies of important older generic drugs. 
Generic Drugs Manufacturing

Counter-Intuitive Thinking To Combat Drug Shortages

Search for solutions to chronic drug shortages may require policymakers to push for payment policies that run counter to the current drug pricing themes, like retrofitting US Medicare’s New Technology Add-On Payments to apply to old, off-patent therapies.
Generic Drugs Manufacturing

Pivot To Video? “Netflix” Rx Pricing Model Plays Well With Media

A subscription model for drug pricing isn’t an entirely new idea, but it is a timely one. If nothing else, the idea of a “Netflix” approach appeals to media savvy audiences. 
Pricing Debate Pricing Strategies

XLH Patient Meeting Showcases Value Of Post-Approval Feedback To US FDA

X-Linked Hypophosphatemia patient feedback meeting follows recent approval of Ultragenyx’ Crysvita. Like an SMA meeting in 2017, it showed how post-approval meetings can help sustain momentum in a new class.
Rare Diseases Approvals

Cleveland Clinic “Outsourcing”? 503B Status Would Be Milestone For US FDA’s Compounding Model

Chronic problem with drug shortages is driving the Cleveland Clinic to consider registering as a 503B “outsourcing” facility. That could be a milestone in FDA’s efforts to encourage the model for high volume compounders.
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