Archive for October 2019
FDA Pilots Accreditation Scheme for Conformity Assessment
The FDA is establishing a pilot accreditation scheme for conformity assessment (ASCA) whereby testing laboratories may be accredited by accreditation bodies to assess the conformance of a device within certain FDA-recognized standards. Source: The GMP Letter
Read MoreEC Releases Guidelines on Benefit-Risk Analysis for Phthalates
The European Commission released final guidelines for devicemakers, notified bodies and regulators on how to perform a benefit-risk analysis for phthalates in medical devices. Source: The GMP Letter
Read MoreFDA’s Top Ten GMP Citations for FY 2019
An FDAnews analysis of the FDA’s Form 483 inspection reports for fiscal year 2019 shows devicemakers continue to be tripped up at the same old hurdles. Source: The GMP Letter
Read More483 Roundup: Five Companies Cited for Various Problems
Five drugmakers were cited in FDA inspections for violations that ranged from inadequate smoke studies to a “cascade of failure” at one facility. Source: Drug GMP Report
Read MoreFDA Warns Galt Pharmaceuticals for Misleading Email
The FDA’s Office of Prescription Drug Promotion (OPDP) sent a warning letter to Galt Pharmaceuticals for sending an email to doctors about its insomnia pill Doral (quazepam) that left out the fact that the drug is a benzodiazepine, a class-four controlled substance. Source: Drug GMP Report
Read MoreFDA 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
Read MoreAveXis 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 FDA’s Form 483 inspection observations. Source: Drug GMP Report
Read MoreWarning 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
Read MoreOnline 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 dosage forms. Source: Drug GMP Report
Read MoreFDA’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
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