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Pharmaceutical companies and clinical research organizations are seeking greater clarity in an FDA draft guidance covering clinical trials with multiple endpoints. 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
The FDA hit Tianjin-Jingye Fine Chemicals with a Form 483 for 14 violations, ranging from inappropriate re-injection and outdated stability research to lack of hand-washing facilities. Read More
A Chinese API maker relied on manipulated data and incomplete records to make decisions on batch releases, prompting the FDA to issue a warning letter to the company over data integrity. 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
The EMA’s Committee for Medicinal Products for Human Use recommended approvals for six drugs within the EU to treat a range of conditions from an endocrine disease to nausea. Read More