GPhA “Generic” Biologics Proposal Includes Directive For FDA Advice
The Generic Pharmaceutical Association is proposing that legislation to create a "generic" biologics process should include a directive to FDA to provide advice to follow-on manufacturers
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US FDA Commissioner Martin Makary’s disavowal of a proposed reorganization plan may be an important turning point in the Trump Administration. The move does not improve the situation, but may mean the administration stops actively making things worse.
Pink Sheet reporter and editors discuss FDA Commissioner Martin Makary’s decision to have one of his assistants lead negotiations for Novavax’s delayed COVID-19 vaccine review, as well as some recent missed review deadlines, which may be the result of recent FDA cuts.