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The European Medicines Agency last month released final guidance 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
The House of Representatives on July 10 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
The European Medicines Agency has initiated a review of human papillomavirus vaccines to determine if product information should be updated, following reports of rare but serious conditions that may be associated with their use. Read More
Hoping to speed development of new treatments for children, the European Medicines Agency is offering drugmakers free meetings with members of its Paediatric Committee. Read More
The European Commission says it does not have the power to issue compulsory licenses to allow the manufacture of generic drugs during a health emergency, noting those decisions are made by member states on an individual basis. Read More
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