Science Board Doubles Membership And Meetings; Will Weigh In On FDAAA
FDA Commissioner Andrew von Eschenbach is attempting to increase the impact of the agency's Science Board Advisory Committee by doubling the number of members and meetings
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Increasing developments in emerging sciences, such as personalized medicine, could reach roadblocks at FDA where limited resources for specialized personnel and advanced equipment may inhibit research, a report from FDA's Science Board's Subcommittee on Science and Technology shows
The hits just keep on coming for Genzyme. On a March 2 call with investors, the firm had to announce not just a "complete response" letter for its 2000-liter scale-up of Myozyme (which will be called Lumizyme for the larger production scale), but also that its Allston Landing manufacturing site had received a 483 report from FDA and a subsequent warning letter
Despite receiving a “complete response” letter and manufacturing warning letter on the same day, Genzyme remains upbeat about the likelihood of approval for its 2,000L scale-up of Myozyme.