In oral arguments in Pliva v. Mensing, justices suggest generic companies have an obligation to ask FDA to revise labeling; Chief Justice John Roberts Jr. says that could lead to boilerplate letters to FDA.
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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A new pilot aims to take Brazil closer to ‘digital transformation.’
The newly reconstituted Advisory Committee on Immunization Practices will create new work groups to examine the cumulative impact of vaccine schedules and reexamine some older vaccines.
Sen. Bill Cassidy and HHS Secretary Robert F. Kennedy Jr. agree the disbanding of ACIP did not violate their agreement, but the perception that Kennedy is not following the spirit of the pledge could be more important long-term.
The CDC Advisory Committee on Immunization Practices had only seven members in place as it met for the first time since HHS Secretary Robert F. Kennedy Jr. dismissed the previous panelists. CDC Director nominee Susan Monarez said finding replacements has been difficult.
