Supplement Bill Increasing FDA Access To Safety Data Planned By Waxman
• By The Tan Sheet
Reps. Henry Waxman (D-Calif.) and Susan Davis (D-Calif.) are working on legislation "that will give FDA greater access to information to understand if a [dietary supplement] product does pose a health risk and will let FDA protect consumers from unsafe products," Waxman said at a July 23 hearing of the House Energy & Commerce/Oversight & Investigations Subcommittee
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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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The Danish Medicines Agency is requesting that data from bioequivalence studies to be submitted in the CDISC format in addition to the current eCTD format. It believes the move will make it easier for the agency claims to access and analyze data and will reduce the burden for applicants.
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