US agency will hold five workshops and develop seven guidance documents focused on patient input in the drug development and review process; since some guidance requirements under Cures law overlap with those in PDUFA VI commitment letter, most of the funding will come from user fees.
FDA's plan for issuing the patient-focused drug development guidance documents required under the 21st Century Cures Act includes numerous public workshops and a slightly more aggressive timeframe for some draft guidances than required under the pending agreement to reauthorize the Prescription Drug User Fee Act (PDUFA VI).
In total, the schedule FDA lays out in its "Plan for Issuance of Patient-Focused Drug Development Guidance Under 21st Century...
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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