Agency and industry also decide to drop research into using social media to enhance post-market safety monitoring.
FDA has placed the breakthrough therapy program on its agenda for potential changes as part of the upcoming PDUFA VI agreement.
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Employers and other health plan sponsors may need to push for better targeted reforms that lower cost sharing for patients.
FDA Commissioner Martin Makary's remarks that his special assistant Tracy Beth Høeg will "be involved in other approval procedures" besides Novavax's COVID-19 vaccine application could be a dramatic change in operations, potentially making the approval system unpredictable.
CEO Len Schleifer said during the company’s first quarter earnings call that most of the complete response letters the company has received related to third-party suppliers, not efficacy or safety.
