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
FDA 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
IMDRF 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:…
Industry 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
FDA 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…
CDER 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)…
483 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
Warning 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.…
Grassley 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
FDA 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…