Lilly GMP “Culture Change” Will Address Compliance Issues, Firm Tells FDA
Lilly is seeking to "affect cultural change" in its approach to GMP compliance, the company assured FDA in a response to the most recent FDA-483 manufacturing report for Forteo and Zyprexa IM
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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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