Monthly Archives: March 2017

US and EU Reach Agreement on Pharmaceutical Inspections

On March 2, 2017 the US FDA and the European Medicines Agency announced that the Agencies had completed an exchange of letters amending the 1998 US-EU Mutual Recognition Agreement.   The exchange of letters is the culmination of nearly three years of work between the two Agencies that began in May 2014 with the initiation of […]

China FDA Launches New Guidelines

Since returning from the country’s New Year Celebration in early February, the China FDA (CFDA) has released a minimum of six new technical review guidelines.  These new guidelines include:  Device:  Bone Filling Materials Class III, Release Date:  February 10, 2017 This technical review guideline addresses bone filling materials (i.e. silicone/calcium phosphorous) are utilized to repair […]