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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FDA hit Tianjin-Jingye Fine Chemicals with a Form 483 for 14 violations, ranging from inappropriate re-injection and outdated stability research to lack of hand-washing facilities.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
Sponsors would like to see clearer recommendations for non-inferiority assessments, demonstrating bioequivalence and targets for statistical analysis, before the European Medicines Agency adopts an international guideline on large clinical trials that span multiple regions. Read More
An alliance of pharmaceutical regulators has voiced concerns about European Commission draft guidelines relaxing some GMP requirements for advanced therapy medicinal products. Read More
The UK’s antitrust regulator alleges that Actavis and Concordia entered a pay-for-delay agreement to block the market entry of generic versions of hydrocortisone tablets and fix prices. Read More
Australia’s Therapeutic Goods Administration increased first-time inspections of drug manufacturing facilities by 16 percent in the second half of 2016, compared to the same period a year earlier, according to the agency’s latest performance report. Read More