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U.S. President Obama announced Sept. 15 his intention to nominate Robert Califf as the next commissioner of the Food and Drug Administration, capping a swift rise for the respected clinical researcher, who assumed the agency’s number two role — deputy commissioner for tobacco and medical products — in March. Read More
Yet another Indian drugmaker has been dinged for serious data integrity and GMP issues — this time during a June 4 to 7 inspection by the World Health Organization. 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
Bristol-Myers Squibb has agreed to pay more than $14 million to settle charges that its joint venture in China made cash payments and provided other benefits to healthcare providers at state-owned and state-controlled hospitals in exchange for prescription sales. Read More
The FDA has reopened the comment period for draft guidance on established conditions for reporting chemical, manufacturing and control changes in NDAs, ANDAs and BLAs. Read More
The FDA has asked Amicus Therapeutics to integrate data from two Phase 3 studies of its Fabry disease treatment migalastat, pushing back its NDA filing until early 2016. Read More