Drugmakers increased the list prices of their drugs far beyond the inflation rate between 2017 and the first quarter of 2019, California found in a first-of-its kind study of 1,020…
Congress has given the go-ahead for a restructuring aimed at improving CDER’s new drug reviews. Source: Drug Industry Daily
Two FDA advisory committees voted 16-8 on Thursday against recommending pediatric labeling for Endo Pharma’s Opana IR (immediate-release oxymorphone). Source: Drug Industry Daily
The FDA cited an OTC drugmaker in California for violations at its facility involving its manufacturing equipment and quality system. Source: Drug Industry Daily
The FDA issued a warning letter to a Chinese drugmaker for significant cGMP violations related to identity testing, process validation and its written stability program. Source: Drug Industry Daily
A federal judge in Florida has thrown out 149 lawsuits in multidistrict litigation alleging Abilify (aripiprazole) caused their compulsive behavior. Source: Drug Industry Daily
China’s National Medical Products Administration is gearing up to implement a unique device identification system and it has created a pilot program that will focus on high-risk implantable devices first.…
The FDA cited six devicemakers for problems with complaint procedures, change controls and quality oversight, among other deficiencies. Source: The GMP Letter
The FDA issued a warning letter to Polymer Technology Systems — doing business as PTS Diagnostics — arising from an inspection earlier this year of its facility in Indianapolis. Source:…
The FDA is making new recommendations to manufacturers of duodenoscopes to transition to new designs that will eliminate the need for reprocessing. Source: The GMP Letter