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GLOBAL REGULATORY AFFAIRS SPOTLIGHTS

Overseas regulators toughen clinical trial stance. December 1, 2008 — 12:03pm ET By John Carroll; Firecebiotech.com.

The Wall Street Journal weighs in this morning with a feature looking at the increasingly tough stance overseas regulators are taking to the clinical trials being conducted around the world. India, for example, is probing the screening measures used in a vaccine trial after a baby in the study died. Polish investigators want to know why two seniors died while taking an experimental bird flu vaccine being developed by Novartis. For additional information, read..


eSubmission—EMEA Key dates and timelines .
- From 1 January 2009, the EMEA will strongly recommend electronic-only submissions, either in eCTD or non-eCTD format (eCTD is the recommended electronic format).
- From 1 July 2009, the EMEA will strongly recommend eCTD-format electronic-only submissions. For additional information, please go to key dates.

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 ...