US FDA upgrades Jubilant's troubled Washington plant to VAI
A Jubilant HollisterStier sterile manufacturing facility hit with a warning letter in 2013 has been upgraded following inspections by the US FDA last year.
Archives for June 11, 2015
US spends billions on irreproducible preclinical studies say researchers
The US spends billions on preclinical research that cannot be replicated due to errors in design, problems with lab protocols and mistakes during data analysis according to new research.
INC launches first SAG to drive earlier insights to protocol development of CNS studies
CRO INC Research has launched the industry’s first Site Advocacy Group (SAG), which will initially focus on central nervous system (CNS) protocols.
FDA offers guidance for running early-phase trials for gene, cell therapies
As the hype continues to hover around the promise of gene and cell therapies, the latest guidance from the FDA will help sponsors, CROs and investigators design early-phase clinical trials for the products, which may pose substantial risks to patients.