We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
A federal appeals court has raised the bar for whistleblowers filing False Claims Act (FCA) suits against drugmakers, saying they must provide specific information about the fraudulent claims made, not just broad allegations about a drugmaker’s conduct. Read More
OTC drugmaker AmeriDerm Laboratories has a long history of failing to test its Paterson, N.J., plant’s water supply for objectionable microorganisms, the FDA says. Read More
The FDA has handed Jubilant HollisterStier a warning letter for quality shortcomings at its Spokane, Wash., sterile drug manufacturing facility. Read More
The FDA issued a Form 483 to Biogen Idec that cites a weakness in the way the company manages suppliers, highlighting the difficulties drugmakers continue to have with supplier quality issues. Read More
Lawmakers want the FDA to explain how hackers broke in to the CBER online submission system to steal personal user information and what the FDA has done to prevent a recurrence. Read More
The EMA said Friday it is investigating Ariad's leukemia drug Iclusig for the risk of blood clots, the same serious adverse event that prompted an FDA investigation and safety alert. Read More
The FDA has approved Auxilium Pharmaceuticals’ Xiaflex biologic injection for Peyronie’s disease, a deformity of the penis caused by a lump of plaque that results in a curvature of at least 30 degrees. Read More
HHS has approved the overhaul of the FDA's Office of Generic Drugs (OGD), allowing the agency to move most of its functions relating to generic drugs under one roof. Read More
The FDA stands by its allegation that Novartis abused the citizen petition process to stall approval of generic versions of Reclast, and the agency has rejected a company request that it retract its statements from the public record. Read More
Generics makers should design tablets and capsules to be similar in size and shape to their reference listed drug (RLD) when they seek ANDA approval, the FDA says. Read More
The FDA may refine its planned quality metrics program to include rankings of individual drugmaker quality — at the request of industry — that will show how a company’s quality system stacks up against its peers. Read More