We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
President Trump released his first budget blueprint yesterday, calling for FDA user fees to rise to more than $2 billion for fiscal 2018 — up from the $1.36 billion set for 2017 — and for $1 billion to fund the 21st Century Cures Act. Read More
Two lawmakers have asked the FDA to explain why the agency approved Marathon’s application to market the old drug Emflaza (deflazacort) as a new treatment for Duchenne muscular dystrophy. Read More
A European Medicines Agency committee proposed changes to clarify ambiguities in an international draft guideline for non-clinical studies of oncology drugs. Read More
India’s Ministry of Health is proposing that drug regulators and drugmakers implement several measures to improve the quality of drugs in the country’s supply chain, following a government estimate that 10 percent of them are substandard. Read More
China’s State Council is ordering the China Food and Drug Administration, and other agencies, to implement stricter policies to reform the country’s regulation of drug prices, GMP compliance and pharmaceutical marketing. Read More
The European Medicines Agency’s working group on good clinical practices and inspections outlined its goals for 2017, including plans to prioritize certain site inspections. Read More