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GLOBAL REGULATORY AFFAIRS SPOTLIGHTS

The 1st All Africa Congress on Biotechnology 22nd-26th September 2008; ‘Harnessing the Potential of Agricultural Biotechnology for Food Security and Socio-Economic Development in Africa’. 06 June 2008. More.

First ever patient administered an siRNA cancer treatment. By Nick Taylor; 05 Jun-2008. In-pharmatechnologist.com. A patient has completed the first successful dosing cycle with small interfering RNA (siRNA) for the treatment of cancer in a clinical trial. The patient was administered with four doses of Calando’s CALAA-01, a targeted siRNA nanoparticle, over a two week period. More ...

Unapproved Cough and Cold Products. 06 June 2008. The U.S. Food and Drug Administration (FDA) has obtained a permanent injunction against Scientific Laboratories Inc. This action bars the firm from making and distributing drug products until its manufacturing operations comply with law and its products are FDA approved. Posted 28 May, 2008. More ...

Pharmacogenomics Guideline Issued: E15: Definitions for Genomic Biomarkers, Pharmacogenomics, Pharmacogenetics, Genomic Data and Sample Coding Categories. Sources: ICH and US FDA. ..Details