Opioid Hearing: Senators Want Speed, But Agency Heads Stress Time, Effort
Reeducating prescribers on treating pain will take a long time, FDA Commissioner Scott Gottlieb tells Senate HELP Committee Members.
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Patient Testimony Highlights Difficulties Of Pain Drug Development, US FDA Regulation Of Opioids
At patient-focused drug development meeting, many patients explained that opioids gave them functionality versus side effects such as suicidal ideation and fatigue that come with other treatments.
Opioid Litigation: Court Asks US FDA To Attend Education Session
Judge overseeing multidistrict litigation convenes meeting with senior pharma executives, government plaintiffs and others to learn about supply-chain dynamics and other issues to resolve more than 200 suits.
Opioid, NME, And Generic Drugs Changes Plotted In US FDA's 2018 Policy Roadmap
‘Better informed patients,’ ‘drug competition,’ ‘biosimilar innovation’ – as well as nutrition and tobacco goals will be achieved through guidances, promotional plans and other items FDA will develop over the next year.