Pearls of Wisdom
Asia Harmonization Working Party releases strategic framework
The Asia Harmonization Working Party (AHWP) is a group of regulatory and industry members who strive to promote voluntary harmonization of medical devices in Asia, in accordance with the Global Harmonization Task Force (GHTF). Established in 1999, the group includes...
FDA requests exemption from EU active pharmaceutical ingredients import laws
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...
HBA Indiana Chapter to host panel discussion on the impact of health care reform in March
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,...
FDA releases list of 2013 future guidance
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...
CDRH increases compliance and enforcement
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...