Industry fought hard to prohibit FDA from having the authority to review marketing plans as part of FDAAA. The REMS for Xenazine suggests that the legislative success may have been a Pyrrhic victory; FDA is going ahead and grabbing authority over the marketing plans and procedures for some drugs.
Biovail Corp. and Ovation Pharmaceuticals Inc. are launching a new drug for Huntington’s chorea called Xenazine. Their marketing efforts involve a third partner: the Food & Drug Administration.
That’s because Xenazine (tetrabenazine) will be marketed in compliance with a mandatory Risk Evaluation & Mitigation Strategy imposed by FDA....
Recent studies show that spaceflight can significantly weaken astronauts’ immune systems, making them more susceptible to infections and health complications during and after missions. Understanding these changes is crucial for ensuring the safety of future long-duration space travelers.
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.
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.
