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Some of the European Medicines Agency’s current recommendations on documenting quality standards for investigational medications will soon be out of date, as the Clinical Trials Regulation comes into effect next year. Read More
The European Medicines Agency has issued final guidance on clinical trial design for drugmakers developing targeted products to treat lupus — in an effort to encourage more companies to target the underserved disease. Read More
The FDA is giving industry and other interested parties another 30 days to weigh in on its request for suggestions on new biomarkers to speed drug development, according to an FDA notice. Read More
The FDA has laid out the procedures drugmakers should follow in preparing for critical path innovation meetings designed to bring drugmakers, patient groups and regulators together to decide how to use experimental and untested methodologies that can advance drug development. Read More
Manufacturers of biosimilar insulin-containing products must demonstrate pharmacodynamic and pharmacokinetic similarity profiles to prove similar efficacy to their reference insulin, the European Medicines Agency says in final guidance issued last month. Read More
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