HPV Vaccine Accelerated Approval May Affect Safety Data Collection
• By The Pink Sheet
The use of accelerated approval for human papilloma virus vaccines could compromise adequate collection of safety data, members of FDA's Vaccines & Related Biological Products Advisory Committee asserted at a Nov. 29 meeting in Bethesda, Md
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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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