Report shows how the FDA incorporates the two ISO standards in its medical device development policy, how the EU version of the two standards differs in significant ways and how the EU Medical Device Regulation may require further changes in the European standards.
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 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