EU Clinical Data Transparency One Step Closer as Draft Regs Approved
The EU will become more competitive thanks to new clinical trial regulations that include data transparency, says rapporteur Glenis Willmott MEP, though industry is opposed.
Archives for June 2, 2013
US House Passes Track-and-Trace Legislation to Secure Supply Chain
The US House of Representatives has passed a bill by voice vote that would for the first time create a system to track and trace drugs through the supply chain.
Keys for CRO Partnerships: Expertise and Cycle Time Reductions, Expert Says
Reducing cycle times and leveraging CRO expertise will drive sponsors’ decisions in choosing partners as they look to reduce costs and oversight obligations, according to a new report.
FDA Warns Hospira Again, This Time in India
Beleaguered Hospira has received another warning letter from the US FDA following an inspection at the company’s India plant in October 2012.
CorePharma: GMP Confident, Ready to Relaunch After FDA Closeout Letter
Three years after receiving a warning letter for GMP violations, CorePharma says it is in a full state of compliance and ready to relaunch products.
USP Delays Deadline for Industry to Comply With Elemental Impurity Standards
USP has decided to delay the implementation of two general chapters on elemental impurities until ICH has further established its own impurity testing requirements.