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The FDA updated several ICH guidance documents to reflect Canada’s adoption of interchangeable chapters from the U.S., European and Japanese pharmacopeias. Read More
The European Medicines Agency is implementing a new form to submit required postmarket data on safety, efficacy and quality, and it is now a mandatory part of Module 1.0 of the electronic common technical document format. Read More
The European Medicines Agency hit a snag in its efforts to publish clinical trial data reports, due to long pilot phases for the first publications it made after the policy took effect last October. Read More
The European Medicines Agency has begun to adopt a new addendum to the ICH’s 1998 clinical trial statistics guideline, as well as a revision to the 23-year-old ICH guideline on measuring drug risks to human reproduction. Read More
The European Medicines Agency revised its 2009 advice to sponsors seeking evaluations of products intended exclusively for markets outside the EU. Read More
The European Medicines Agency stands to lose nearly one-fifth of its staff when it leaves London, no matter which city in the European Union is selected for its new headquarters, a survey of the EMA workforce showed. Read More
A new pricing agreement will allow a leading HIV regimen to be rolled out in more than 90 low- to middle-income countries, at an average cost of $75 per patient, per year. Read More