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China is opening its market to biosimilars, issuing the country’s first-ever guideline on the technical review of the products and criteria for establishing biosimilarity. Read More
Sponsors of clinical trials in India must begin reporting all deaths that occur “in clinical trials,” under final guidance issued in early March by the Central Drugs Standard Control Organization. Read More
China’s drug approval backlog ballooned to nearly 18,600 applications by the end of 2014, up more than 30 percent from December 2013, with generics applications representing most of the increase. Read More
Chinese leaders want drugmakers to stop using third-party distributors and sell directly to hospitals in an effort to curb corruption in the supply chain. Read More
The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee will meet Tuesday to review the safety of DPP4 inhibitors, a class of diabetes drug the FDA first approved in 2009. Read More
The FDA has granted Shire’s dry eye treatment lifitegrast a priority review, cutting its NDA review time to six months rather than the usual 10 months. Read More
Drugmakers making major alterations to their products will require a different EU number if they change the specifications or the amount of units contained in a pack, under updated guidelines in Europe. Read More
Australia’s Therapeutic Goods Administration is turning to the European Union for guidance as it seeks to adopt 10 guidelines — four new and six replacements — to improve the nation’s drug system. Read More
An FDA request for feedback on its drug compounding regulations is likely to generate questions and comments on GMPs, office-use compounding of nonsterile drugs and more, experts say. Read More