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The FDA is trying to reassure drug companies by making it clear that the agency won’t use its quality metrics collection to spur 483s, warning letters and other enforcement actions. Read More
The FDA has fast-tracked the third potential treatment for Duchenne Muscular Dystrophy this year, granting the designation to New Jersey-based Tarix Orphan for its TXA127. Read More
The FDA has granted priority review status for three sNDAs for Bristol-Myers Squibb’s Daklinza, potentially expanding the firm’s footprint in the roughly $13 billion U.S. hepatitis C market. Read More
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
Drugmakers submitting an NDA or BLA with a tropical disease priority review voucher in the U.S. will now pay a $2.7 million fee — a $165,000 increase over fiscal year 2015, which ended Sept. 30. Read More
Despite its lucrative promise, the U.S. Food and Drug Administration’s priority review voucher program has done little to spur development of novel treatments for tropical and rare pediatric diseases, a new study in JAMA concludes. Read More