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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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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.

The Economics Of Drug Shortages: US FDA Seeks Broad Input

FDA is planning series of stakeholder meetings to identify new approaches to drug shortages, with particular interest in defining “essential” drugs. Agency is also looking outside for expertise, with Boston University’s Rena Conti tapped as advisor.
Manufacturing Regulation

Breathing Life Into Inhaled Antibiotics: US FDA Tries To Move Class Ahead After Two Rejections

Workshop on inhaled antibiotics serves as unusual post mortem after two public rejections at advisory committee level; agency clearly eager not to see development in field end.  
Infectious Diseases Drug Approval Standards

MedPAC Analysis Of 'Low-Value' Medicare Treatments Spotlights Acthar

The Medicare Payment Advisory Commission’s annual 2018 report to Congress features the flip side of the recent value-based rhetoric – highlighting “low-value” Medicare purchases. The drug chosen to make that argument is Mallinckrodt’s HP Acthar Gel.   

Pricing Debate Medicare

Biodefense Bill Moving In Senate; Still Debate Over Best Approach For Flu

US Pandemic and All Hazards Preparedness Act appears on track for on-time reauthorization – but there may still be debate over whether and how to dedicate funding specifically for pandemic flu preparedness and stockpiling.
Infectious Diseases Legislation

NSAID Comparative Safety: PRECISION Study, FDA Pertinacity … And Anti-Clotting Agents?

US FDA's planned advisory committee on comparative safety in the NSAID/COX inhibitor area shows agency's staying power on safety issues.  
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