Archive for September 2019
California Finds Drugmakers Increased List Prices Way Above Inflation
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 drugs based on the state’s mandatory wholesale price reporting requirements. Source: Drug Industry Daily
Read MoreCDER Reorganization Gets Under Way
Congress has given the go-ahead for a restructuring aimed at improving CDER’s new drug reviews. Source: Drug Industry Daily
Read MoreAdvisory Committees Turn Down Opana IR Pediatric Labeling
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
Read MoreCalifornia OTC Firm Written Up for Missing Validations, Product Reviews
The FDA cited an OTC drugmaker in California for violations at its facility involving its manufacturing equipment and quality system. Source: Drug Industry Daily
Read MoreFDA Warns Chinese Firm for Testing, Validation Failures
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
Read MoreFederal Judge Dismisses 149 Lawsuits over Abilify’s Side Effects
A federal judge in Florida has thrown out 149 lawsuits in multidistrict litigation alleging Abilify (aripiprazole) caused their compulsive behavior. Source: Drug Industry Daily
Read MoreChina Launches Pilot Program for Unique Device Identifier System
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. Source: The GMP Letter
Read More483 Roundup: FDA Flags Six Firms for GMP, Other failures
The FDA cited six devicemakers for problems with complaint procedures, change controls and quality oversight, among other deficiencies. Source: The GMP Letter
Read MoreFDA Issues Warning to Indiana Devicemaker
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 GMP Letter
Read MoreDuodenoscopes Need Better Designs to Avoid Reprocessing, FDA Says
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
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