Merck Marketing, Pricing Practices Lead To Settlement With Justice Dept.

Merck's $650 million settlement with the Department of Justice to resolve state and federal investigations into payment of Medicaid rebates and incentives to health care workers will act as a deterrent to other drug makers, the agency said

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US FDA’s Makary Floats Vague ‘Plausible Mechanism’ Approval Pathway For Rare Diseases

 

Ascertaining the novelty and benefits of Makary’s new drug approval idea – along with what it would take to implement it – requires more clarity on the types of studies he envisions being used to grant and confirm “plausible mechanism’ approvals.

Confirmatory Trials: Industry Wants Timely Protocol Feedback, More Clarity On ‘Due Diligence’

 
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Consumer and academic group comments on accelerated approval and confirmatory trial guidances say the proposed criteria for determining when a study is underway are too vague.

Industry Highlights Issues With EU HTA Regulation’s PICO Framework For Vaccines

 

Vaccine developers should be aware that the framework underpinning the new EU Health Technology Assessment (HTA) Regulation might not be suitable for immunizations, but actions from policymakers and industry could help mitigate some issues, a senior figure from GSK says.