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A European Medicines Agency committee proposed changes to clarify ambiguities in an international draft guideline for non-clinical studies of oncology drugs. Read More
Two congressmen sent a letter to the CEO of Marathon Pharmaceuticals, calling the company’s decision to market an old drug for Duchenne muscular dystrophy for $89,000 per year as “outrageous” and “unconscionable.” Read More
CDER and CBER published agendas of draft guidances planned for the 2017 calendar year, covering required pediatric study compliance and pediatric oncology development, recommendations for adaptive clinical trial designs, and the development of standards used in biologics submissions. Read More
Sponsors seeking approval for an interchangeable biosimilar should plan to conduct a switching study using a U.S.-licensed comparator product and primary endpoints that assess clinical pharmacokinetics and pharmacodynamics. Read More
Italian regulatory authorities have ordered a ban on drug substances and bulk products manufactured by Antibióticos Do Brasil after an inspection revealed several GMP deficiencies, ranging from data integrity to quality management issues. Read More