by Raleigh Malik | Feb 11, 2013
In an effort to decrease manufacturer’s admin, prevent possible drug shortages and encourage globalization, the US requested exemption from the new European Union (EU) import laws for active pharmaceutical ingredients (API)s. The exemption would place the US FDA on a...
by Raleigh Malik | Feb 7, 2013
The Healthcare Businesswomen’s Association (HBA) Indiana Chapter is presenting a panel discussion on the healthcare reform that goes into effect in 2014. Join government leaders and industry professionals as they discuss the impact of the reform on states, insurers,...
by Raleigh Malik | Feb 6, 2013
The FDA released a list of guidance documents that it is planning to publish in the 2013 calendar year. Guidance on quality agreements for contract manufacturing organizations (CMOs) and biosimilar developers in 2013 is included in the list. To see the FDA list of...
by Raleigh Malik | Feb 6, 2013
A recent report by Greenleaf Health consultancy indicates that the Center for Devices and Radiological Health (CDRH) has increased enforcement activity compared to previous years per an article on mddionline.com. The report, led my former FDA associate commissioner...
by Raleigh Malik | Feb 6, 2013
We are thrilled to announce our partnership with the state of Indiana to expand, and especially proud of all of the past week’s news coverage. Upon announcement of expansion, the company enjoyed several mentions in online news outlets, and Pearl was featured on the...