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The FDA’s new team-based inspection program is starting to take shape with a steering committee led by high-ranking FDA officials and three subgroups. Read More
The FDA’s new proposed team-based inspection program completed initial inspections in its ongoing pilot and was deemed a huge success that helped investigators plan better inspections. Read More
The Patent Trial and Appeal Board has invalidated a patent for Novartis’ multiple sclerosis drug Gilenya, in one of the first successful uses of the inter partes review process by generics drugmakers. Read More
Presidential candidate and Senate HELP Committee member Bernie Sanders said Friday that he plans to vote against confirming Robert Califf as the new FDA commissioner, citing Califf’s strong ties to industry. Read More
Drugmakers are urging the FDA to clarify how and why the consumer brief summary in direct-to-consumer print advertisements should differ from FDA-approved patient labeling and medication guides. Read More
The FDA is planning two surveys of 900 adults each to assess the effect of including more complicated information about prescription drugs in direct-to-consumer television advertisements. Read More