FDAnews
www.fdanews.com/articles/138590-fda-ema-collaborating-to-create-harmonized-biosimilars-review-path

FDA, EMA Collaborating to Create Harmonized Biosimilars Review Path

July 21, 2011
The FDA and European Medicines Agency (EMA) have agreed to work together toward harmonizing biosimilars regulations, which may help the FDA catch up in its development of an abbreviated pathway to approve the generic biologics.
Generic Line