News & Analysis on Clinical Trial Services & Contract Research And Development
The Food and Drug Administration (FDA) have high hopes for the fourth revision of the Prescription Drug User Fee Act (PDUFA), which has proved its worth by cutting review times by up to 24 months since its introduction in 1992.
US firm Abraxis BioScience has been issued a firm warning by the Food and Drug Administration (FDA) following concerns about contamination of drug products and marketing violations for several drugs.
Biotechnology firm Codexis has launched its Codex biocatalyst panels, which promise to increase R&D and manufacturing productivity while reducing cost.
Bristol-Myers Squibb (BMS) has spent $3.65m (€2.78m) on an 89-acre plot of land to build a new bulk biologics manufacturing facility in Devens, Massachusetts.