Yale signs agreement with Belgian med device CRO
Yale University’s Cardiovascular Research Group (YCRG) and medical device CRO genae associates nv, have announced a collaboration and co-marketing agreement for cardiovascular devices.
Archives for October 15, 2013
Carry over funding will run out soon says US FDA as Gov shutdown continues
The US Food and Drug Administration (FDA) will soon run out of funding for the limited amount of medical product regulatory work it has carried out during the Government shutdown according to an agency spokesman.
Regulatory approval for CMC Biologics' upgraded Danish plant
CMC Biologics has received renewal of its GMP credentials from the Danish Medicines Agency (DKMA) after upgrading the manufacturing capacity at its Copenhagen site.
UK’s MHRA suspends Wockhardt certificate as Indian generic firms complain of shifting standards
The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has withdrawn its good manufacturing practice certificate for Wockhardt’s Chikalthana, India-based plant due to cGMP violations.
US FDA Releases ICH Draft Guideline on Elemental Impurities
The US FDA has released the ICH’s guideline on elemental impurities for public comment a little more than two months after the ICH did the same.
Quintiles shutters Phase I unit in India
CRO Quintiles has decided to close its Phase I unit in Hyderabad, India, because of a “challenging external business environment,” a company spokesman told us.