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The European Medicines Agency released final guidance June 10 on the primary and secondary endpoints sponsors should use to evaluate drugs to treat acute heart failure — along with recommendations on designing and conducting such studies in children. Read More
Canada lags significantly behind other developed countries in providing coverage for new medicines, with Canadians waiting on average 462 days for novel, potentially lifesaving drugs, a new report shows. Read More
The number of critical deficiencies at pharma facilities registered in the UK nearly doubled from 2012 to 2013, spurred mainly by problems with data integrity, regulators say. Read More
The European Commission will revise four sections of its good manufacturing practice guideline and add a new one, as it moves to harmonize GMPs with international standards and speed the path to mutual reliance with foreign regulators, a UK official says. Read More
The U.S. Food and Drug Administration expects to boost its China office staff to 35 within the next two years and its India staff to 23 as the agency focuses on increasing inspections in both countries. Read More
India’s national drugs authority will hire 147 inspectors this year to ensure adherence to good manufacturing practices, but training will determine success, an observer says. Read More
The FDA is requiring stronger label warnings for non-aspirin nonsteroidal anti-inflammatory drugs, after a comprehensive review of new safety information affirmed an increased risk of heart attack or stroke. Read More
The House of Representatives Friday approved the 21st Century Cures Act by a vote of 344 to 77, moving focus to the Senate where efforts have begun to develop comparable legislation. Read More