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Starting next year, drugmakers will be able to see how well Australia’s Therapeutic Goods Administration has performed on outcomes-based metrics, thanks to a new evaluation scheme adopted by the government. Read More
The European Medicines Agency issued revised guidance on classification of advanced therapy medicinal products and the information that sponsors need to submit to the agency. Read More
Australia’s Therapeutic Goods Administration has adopted 10 EU guidelines, four that are new for the country and six that replace existing guidelines. Read More
Sponsors of new drugs to treat cardiovascular and metabolic diseases should use a composite of all major cardiovascular events as the primary endpoint in studies to establish CV risk, the European Medicines Agency says. Read More
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