Senate legislation to reform the US OTC monograph process mirrors the House draft proposed in January, including a two-year market exclusivity provision for some products. The Consumer Healthcare Products Association says it is working with legislators and is encouraged a reform bill will pass this year.
Introduction of a Senate OTC monograph reform bill largely tracking a House discussion draft – including two-year market exclusivity for some products – provides “great encouragement” Congress this year will pass legislation to improve the FDA program, says the Consumer Healthcare Products Association.
The “Over-the-Counter Drug Safety, Innovation and Reform Act,” S.2315, like a discussion draft in the House, proposes streamlining...
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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