Formal Supplement Advisory Committee Not Necessary, NNFA's Ford Tells FDA
• By The Tan Sheet
A voluntary advisory committee combining academia, consumer groups, industry, Congress and FDA would help the agency through some of the "issues" where it needs "assistance" in developing a strategic plan for dietary supplement regulation under the Dietary Supplement Health & Education Act, National Nutritional Foods Association President Michael Ford said at an FDA stakeholder meeting in Washington, D.C. June 8.
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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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Commissioner Martin Makary’s repeated characterization of foreign facilities as being subject to lower standards than domestic counterparts may have contributed to Rogers’ decision to retire as head of the recently formed Office of Inspections and Investigations.
Cooperation between health technology assessment bodies across the EU will lead to a better joint clinical assessment process over time, but patients cannot afford a lengthy wait for improvements, speakers at a cell & gene therapy conference said.