Senate HELP Committee unanimously advances bill that would also boost FDA's power over unit dose packaging and improve inspection of international mail facilities.
The US Senate Committee on Health, Education, Labor and Pensions unanimously voted to advance an opioid package that would require the US FDA to clarify the development and regulatory pathways for non-addictive and non-opioid pain medications by a 23-0 margin.
The Opioid Crisis Response Act of 2018 (S.2680) got the nod from the HELP Committee at an April 24 markup...
With the US BIOSECURE Act waiting for a Senate vote, there are signs it may be prompting some Chinese firms to look at their operations. In the meantime, two legal experts in China suggest a range of coping strategies for companies that may be deemed "of concern."
As the reform of the EU pharmaceutical legislation progresses through the legislative process, the Pinks Sheet offers an infographic highlighting some of the key changes being proposed that will reshape the way drug companies run their business.
US lawmakers will undoubtedly continue to work on pharmacy benefit manager reform legislation in 2025, given its bipartisan support. But policies impacting rebates that could lead to higher premiums in Part D may be a tough sell in the midst of the benefit redesign.
Neither Kamala Harris nor Donald Trump mentioned drug pricing reforms in their presidential convention speeches.
It is unclear in a revised staff manual guide whether Commissioner's National Priority Voucher program approval “recommendations” from the drug and biologic center directors will be advisory or decisional, experts told the Pink Sheet.
Revised recommendation is based on most recent data on circulating strains in US, where KP.3 is now dominant. Novavax sticks with plans targeting the JN.1 ‘parent strain.’
Pink Sheet reporter and editors discuss the US FDA’s changes to the COVID-19 vaccine indication and its revocation of the vaccine emergency use authorizations, as well as new vaccine coverage and reimbursement questions.
