The US Food and Drug Administration's drug center plans to issue 102 new and revised draft guidances during calendar year 2016, including those on use of multiple endpoints in clinical trials, 180-day exclusivity, and abbreviated new drug application (ANDA) refuse-to-receive standards.
The US Food and Drug Administration's drug center plans to issue 102 new and revised draft guidances during calendar year 2016, including those on use of multiple endpoints in clinical trials, 180-day exclusivity, and abbreviated new drug application (ANDA) refuse-to-receive standards.
The Center for Drug Evaluation and Research's guidance agenda1 includes two guidances on biosimilarilty: labeling for biosimilar products, and statistical...
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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.’
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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