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Opioid Hearing: Senators Want Speed, But Agency Heads Stress Time, Effort

 
• By Michael Cipriano

Reeducating prescribers on treating pain will take a long time, FDA Commissioner Scott Gottlieb tells Senate HELP Committee Members.

Capitol House

Members of the Senate Committee on Health, Education, Labor and Pensions stressed the need for speed on efforts to combat the opioid epidemic at an Oct. 5 hearing, but public health agency heads cautioned that some of the new initiatives are going to take years to have an impact.

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

 
• By Sarah Karlin-Smith

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’

 
• By Sue Sutter

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

 
• By Eliza Slawther

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.