Agency would be allowed to require blister packaging for approved opioids, and would have to do more to coordinate with US Customs and Border Protection to detect illicit drugs at the border, under legislative proposals unveiled by Senate HELP Committee Chairman Lamar Alexander.
Two discussion drafts of legislation from Senate Health, Education, Labor and Pensions (HELP) Committee Chairman Lamar Alexander, R-Tenn., appear to broadly reflect the US FDA's priorities for addressing the opioid epidemic in the realms of packaging and border security.
Draft legislation aimed at improving FDA's statutory authorities for opioids would allow the agency to require opioid manufacturers to...
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.
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.
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