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.
The FDA issued a warning letter to a South Korean OTC manufacturer Dermameal for violations at its facility in Gyeonggi-do, including the incomplete quality testing and an inadequate stability program. Read More
Fort Worth drugmaker CBI Laboratories was slapped with a Form 483 for multiple violations at its facility including a flawed quality unit, the lack of annual product reviews and a failure to conduct cleaning validations. Read More
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. Read More
Novartis subsidiary AveXis placed the blame for data manipulation over its $2 million spinal muscular atrophy drug Zolgensma squarely on two former senior executives, in a lengthy response to the FDA’s Form 483 inspection observations made public on Tuesday. Read More
Staff admitted that the facility stopped testing for the active ingredient because they had “previously obtained consistent passing results,” the agency said. Read More
Results of a phase 3 clinical trial which showed that 67 percent of patients treated with the therapy could tolerate up to 600 milligrams of peanut protein with no more than mild to moderate symptoms. Read More
With less than two weeks to go in fiscal 2019, an FDAnews analysis of the FDA’s GMP inspection reports for the year shows that drugmakers continue to stumble at the same old hurdles. Read More