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The FDA said it will delay its “intended use” rule governing when tobacco products are to be classified as drugs, devices or combination products. Read More
Four former FDA commissioners have called on Congress to abandon proposals that would allow drug imports, warning that such measures would come with substantial risks and only have a small effect on prescription drug costs and access. Read More
The EU Court of Justice has denied the European Medicines Agency appeals to allow the agency to release documents as part of its transparency efforts. Read More
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