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The European Medicines Agency conducted 350 good manufacturing practices inspections in the first half of this year — roughly 50 percent more than in the same period a year ago, a new report shows. Read More
Alkermes is preparing to launch its schizophrenia drug Aristada in the U.S. following FDA approval Monday — making it the latest generic to threaten Otsuka’s grasp on the multibillion dollar antipsychotics market via Abilify. Read More
Sen. David Vitter (R-La.), is asking the FDA to process its current backlog of more than 3,000 generic drug applications, especially in light of recent prescription drug price increases. Read More
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
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The FDA has reopened the comment period for draft guidance on established conditions for reporting chemical, manufacturing and control changes in NDAs, ANDAs and BLAs.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
U.S. companies taking new biologicals to 11 Pacific Rim nations would get no more than eight years of marketing exclusivity — four less than what they enjoy in the U.S. — under a trade deal agreed to by all 12 countries. Read More