FDA “Progressive Approval” And “Exceptional Approval” Pathways Possible Under Senate Bill
Legislation being drafted by Sen. Kay Hagan, D-N.C., would formalize FDA practices of approving drugs in certain circumstances where the evidence needed for a standard approval cannot be generated.
Learn what's happening at the US FDA. On the go.
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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."
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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.
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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.
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Neither Kamala Harris nor Donald Trump mentioned drug pricing reforms in their presidential convention speeches.
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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.’
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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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To make your document look professionally produced, Word provides header, footer, cover page, and text box designs that complement each other. For example, you can add a matching cover page, header, and sidebar. Click Insert and then choose the elements you want from the different galleries.
