FDA Offers More Time to Join Quality Metrics Feedback Program
The FDA has reopened the submission period for its quality metrics feedback program, giving potential participants more time to sign up. Source: Drug GMP Report
AveXis Issues Detailed Response to Zolgensma Form 483
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…
Warning Letter Roundup: Three Firms Slapped for Quality Issues
The FDA hit three overseas drugmakers for violations at their facilities that included testing deficiencies, a lack of cleaning validation and other slipups. Source: Drug GMP Report
Online Pharmacy Urges FDA to Pull All Ranitidine Products
Online pharmacy Valisure petitioned the FDA to recall and suspend the sale of all ranitidine-containing products in the U.S., claiming it found high levels of NDMA across multiple manufacturers and…
FDA’s Top Ten GMP Inspection Findings for FY 2019
An FDAnews analysis of the FDA’s GMP inspection reports for fiscal 2019 shows that drugmakers continue to stumble at the same old hurdles. Source: Drug GMP Report
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…
CDER 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
Advisory 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
California 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
FDA 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
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