FDA clarifies reporting of adverse events in clinical trials
The FDA has issued a final rule and draft guidance that clarifies what clinical trial safety information must be submitted to the agency.
Archives for September 28, 2010
Venus to supply docetaxel to Thailand
Venus Remedies is supplying docetaxel to Thailand after a compulsory license was issued to make the drug more affordable.
Xcelience adds dry granulation tech to ease scale-up
Xcelience is shortening scale-up time from development to GMP production of clinical trial materials through the installation of dry granulation technology.
61% of NIH registered trials use sites outside North America
From 2005 to 2009 61 per cent of US NIH registered trials included at least one study site outside North America. Outsourcing-Pharma presents this, the 2009 downturn in US trials and other data as an interactive visualisation.
Chinese cancer drug brings HUYA and Quintiles together
HUYA Bioscience International will co-develop a new Chinese cancer drug, HBI-8000, with Quintiles for the “benefit of cancer patients globally.”
FDA, NIH funding nano study to advance regulatory science
The US FDA and NIH are funding research into bioinformatics-modelling of nanoparticles as part of a collaborative initiative to advance regulatory science.
Chemically defined supplements boost Sheffield Bio-Science's product portfolio
Sheffield Bio-Science takes on responsibility for global sales, distribution and development of Girus Life Sciences’ chemically defined Regocel supplements.