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January 20, 2011
The EU Commission is on the lookout for "potentially problematic patent settlements" and has asked several pharma companies to submit copies of their patent settlement agreements made between originator and generic companies.
January 07, 2011
Iain Moore explains what progress has been made so far regarding EU plans to regulate excipients.
Excipients should be regulated to manage risk. Although, excipients are an integral part of a finished pharmaceutical product, the issue of regulation is complex.
January 02, 2011
Holding product and supply-chain security to the highest standards is crucial for the future.
December 23, 2010
The European Medicines Agency launched on December 20, 2010, a public registry about small and medium-sized enterprises (SME) that includes information about SME-registered companies.
November 18, 2010
The International Conference on Harmonization (ICH) Steering Committee (SC) and its working groups met in Fukuoka, Japan Nov. 6-11, 2010.
October 14, 2010
The European Medicines Agency (EMA) has adopted new policies on access to documents and the handling of conflicts of interest
August 26, 2010
GlaxoSmithKline Consumer Healthcare, Cephalon UK Ltd, and ProStraken Group plc have been accused of breaching the Association of the British Pharmaceutical Industry's (ABPI) Code of Practice.
August 05, 2010
Legislative efforts to modernize provisions in the Toxic Substances Control Act of 1976 (TSCA), which involve chemical safety and reporting requirements is drawing criticism from the chemical industry.
August 02, 2010
The authors discuss the statistical tools used in experimental planning and stategy and how to evaluate the resulting design space and its graphical representation.