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’s Committee for Medicinal Products for Human Use recommended marketing authorizations for 92 drugs and biologics in 2017, an increase from 81 in 2016 but down from 93 in the previous year. Read More
The European Medicines Agency’s Committee for Medicinal Products for Human Use recommended seven new products for European Commission approval, including one biosimilar and two orphan medicines, one being an advanced cell therapy. Read More