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Members of both parties have been critical of benefits managers, with some condemning them as “middle-men” who needlessly drive up the cost of drugs. Read More
Ionis, Merck and Lundbeck offered feedback on the FDA’s guidance for developing natural history studies for rare disease drug development, praising some parts of the guidance but calling for more details. Read More
Congressional panels have taken turns bashing benefits managers as “middlemen” who inflate the cost of prescription drugs while adding little to the drug supply chain. Read More
The EU also recognizes the regulatory oversight of active substances by competent authorities in the U.S., Australia, Brazil, Israel, Japan and Switzerland. Read More