A lack of data integrity often is “just fraud,” says Howard Sklamberg, FDA deputy commissioner for global regulatory operations and policy. read more

The Low Endotoxin (LER) and Lipopolysaccharide Recovery (LLR) phenomena have been debated as a Limulus Ameobocyte Lysate (LAL) test validity issue peculiar to therapeutic monoclonal antibodies for over three years. The FDA... read more

Low endotoxin recovery (LER) was first described publicly at the PDA Annual Meeting in Orlando Florida, in April, 20131 but the phenomenon has been observed by pharmaceutical scientists for years, mostly as classical “... read more