House Appropriators Call For CMS To Pay More For Domestic Generic Drugs And Biosimilars
Committee report sets manufacturing reshoring agenda for CMS and other HHS agencies like BARDA and ASPR that includes piloting new payment and reimbursement policies, strengthening domestic API production capabilities, and developing more flexible pharmaceutical manufacturing technologies that could add surge capacity.
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In the first of a three-part series on the evolution of mRNA manufacturing, this article looks back to before the pandemic, when dogged mRNA researchers and entrepreneurs labored in obscurity pursuing the dream of revolutionizing health care by commandeering the body’s own protein building process to generate quicker, cheaper vaccines and therapeutics. Then the mRNA COVID-19 vaccines stunned the world.
The US FDA has issued guidance on how it will continue to use remote technology to assess agency regulated facilities, a practice that became popular during COVID-19 travel restrictions.
Agency provides additional details on plans for various remote methods of assessing Rx and OTC drug manufacturing facilities that became popular when investigators were prevented by COVID-19 travel restrictions from visiting sites in person.