The Senate Health, Education, Labor and Pensions (HELP) Committee and House Energy and Commerce Health Subcommittee each passed bills this week to expedite approval pathways for non-opioid devices and drugs to control pain and prevent further addictions. Other opioid bills passed by the House subpanel seek to remove reimbursement challenges for opioid-alternative pain control devices.
As part of an overall effort by the US Congress to stop the ongoing opioid epidemic, a key Senate Committee and House subcommittee approved bills this week to expedite approval of non-addictive devices and drugs that could serve as alternatives to opioids for control of acute and chronic pain.
On April 24, the Senate HELP Committee passed the “Opioid Crisis Response Act of 2018,” onto the full Senate. A provision in the bill calls on FDA to hold public...
The UK has issued clearer guidance to help drug and medical device sponsors demonstrate how they intend to include a diverse and relevant range of participants in their clinical trials.
Moves are at last underway for a more specific focus on orphan and pediatric devices. They are a start; but experts are calling for more to support this sector.
Fujirebio Diagnostics' Alzheimer's disease test, Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio, has been cleared by the US FDA.
