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The agency can collect backlog fees from holders of ANDAs that were pending on Oct. 1, 2012 and did not receive a tentative approval prior to that date. Read More
A New York judge has set a Jan. 20 trial date for opioid litigation led by the state’s attorney general against opioid manufacturers and distributors. Read More
The FDA, EMA and Japan’s Pharmaceuticals and Medical Devices Agency have made strides toward aligning clinical trial designs for antibacterial drug indications, the regulators announced following their fourth tripartite meeting in Tokyo. Read More
The Department of Health and Human Services slapped Gilead with a patent infringement suit in a federal court on Tuesday over its HIV drugs Truvada and Descovy. Read More