Congress’s failure to pass a government funding bill last weekend means much — but not all — of FDA’s work will stop until an appropriations bill is passed. Source: Drug…

The FDA warned Chinese drugmaker Yicheng Chemical for inadequate documentation and manufacturing methods that could cause potential cross-contamination. Source: Drug Industry Daily

Merck and Glenmark engaged in anticompetitive behavior by keeping a generic version of Zetia off the market, creating a monopoly and manipulating the drug price, according to a newly filed…

Janssen filed suit in a federal court against Teva last week alleging patent infringement of its schizophrenia drug Invega Sustanna — a product that brought in more than $2 billion…

CDER published an agenda of 98 upcoming draft guidances for the 2018 calendar year — including new recommendations for developing treatments for Alzheimer’s and amyotrophic lateral sclerosis. Source: Drug Industry…

Five health systems representing hundreds of U.S. hospitals plan to establish their own non-profit generic drug company to address drug shortages and bring competition to the generic drug market. Source:…