Archive for September 2019
Russia Implements New Quality Control Requirements
Russia’s Ministry of Health has rolled out new requirements for internal quality control and monitoring of the safety of devices in medical facilities. Source: The GMP Letter
Read MoreFDA Hits Houston Devicemaker With Lengthy Warning Letter
Houston-based medical devicemaker Talon received a lengthy FDA warning letter for design process and quality control issues following an inspection of the firm’s manufacturing facility. Source: The GMP Letter
Read MoreIMDRF Seeks Feedback on Adverse Event Reporting Terms
The International Medical Device Regulators Forum (IMDRF) has issued a new draft document on harmonizing terminology and codes for reporting adverse events for medical devices and in vitro diagnostics. Source: The GMP Letter
Read MoreIndustry Questions EU Specifications for Reprocessing Single-Use Devices
Devicemakers have raised concerns about the European Commission’s proposed specifications for reprocessing single-use devices. Source: The GMP Letter
Read MoreFDA and NIIMBL Team Up on Advanced Manufacturing
Following an agency-wide e-mail from the Acting FDA Commissioner marking an increased focus on emerging technologies, the agency has forged a research partnership with the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) to spur innovation in advanced manufacturing. Source: Drug GMP Report
Read MoreCDER Plans Pilot to Test Clinical Data Interchange Standard
The FDA is planning a small pilot program to test how it handles nonclinical study data submitted electronically in SEND 3.1 format — a Clinical Data Interchange Standards Consortium (CDISC) standard the agency has moved towards to gather more study data. Source: Drug GMP Report
Read More483 Roundup: Seven Companies Cited for Quality Transgressions
The FDA hit seven drugmakers for quality-related violations, including issues with shared equipment and complaint evaluation. Source: Drug GMP Report
Read MoreWarning Letter Roundup: Facilities Scolded for Multiple Slipups
The FDA issued warning letters to four firms for a variety of violations, including testing issues, invalidating out-of-specification test results without justification and the use of untested water in manufacturing. Source: Drug GMP Report
Read MoreGrassley Calls for Unannounced Inspections of Foreign Drugmakers
Sen. Chuck Grassley (R-Iowa) has urged the FDA to begin inspections of all overseas drug manufacturing facilities without prior notice. Source: Drug GMP Report
Read MoreFDA Inspection of Novartis Lab Raises More Questions About Data Falsification
A Form 483 issued following an FDA inspection of Novartis subsidiary AveXis’ control testing laboratory — currently the focus of a data manipulation investigation by the agency — is raising concerns about the firm’s own investigation and when it knew about the data discrepancies. Source: Drug GMP Report
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