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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
The FDA hit Laboratorio Reig Jofre for numerous violations at its Barcelona sterile drug manufacturing facility, including inadequate smoke studies and failing to qualify contract service providers. Read More
South Korean OTC drug manufacturer Enprani drew a warning letter from the FDA for CGMP violations observed by FDA investigators at its Incheon facility — including the release of products for sale in the U.S. without checking the identity and strength of their active ingredients. Read More