Archive for August 2019
Industry Supports Reclassification of Surgical Staplers, But Adds Caution
Most comments on the FDA’s draft guidance for reclassifying surgical staplers supported the move to reclassify devices from Class I to Class II but some cautioned that the rule could adversely affect access to the products. Source: The GMP Letter
Read MoreFDA Warns Clinicon for Lax Testing, Validation of Sterilization Processes
The FDA issued a June 20 warning letter to Clinicon for quality system lapses related to its SureProble Class II sterile probe following an April 3-4 inspection of the firm’s Oceanside, California facility. Source: The GMP Letter
Read MoreFDA Finalizes Guidance on Postmarketing Safety Reporting for Combination Products
The FDA has issued a final guidance on postmarketing safety reporting (PMSR) requirements for combination products. Source: The GMP Letter
Read MoreU.S. Urges EU to Delay Implementing EU MDR/IVDR by Three Years
With only nine months to go before the EU’s Medical Device Regulation hits its May 26 application date, the U.S. is pressing the EU to delay implementation for another three years. Source: The GMP Letter
Read MoreFDA Releases Recommendations on Using the Inactive Ingredient Database
The FDA issued draft recommendations for drug developers on how to make the best use of the agency’s online database of inactive ingredients. Source: Drug GMP Report
Read MoreWHO Issues Revised Guidance on QMS Requirements
The World Health Organization (WHO) has released updated guidance for quality management system (QMS) requirements for national inspectorates aimed at aligning its content to international standards, the latest QMS principles and to expanding its scope. Source: Drug GMP Report
Read More483 Roundup: FDA Hits Six Drugmakers for GMP Violations
The FDA cited six manufacturers for a variety of issues, including cross-contamination, complaint handling and quality system failures. Source: Drug GMP Report
Read MoreFDA Warns Three Drugmakers for GMP Slipups
Three U.S. drug manufacturers were hit with warning letters over shortcomings encountered at their facilities, including data integrity concerns, improper equipment calibration and unproven water systems. Source: Drug GMP Report
Read MoreFDA Posts Final Guidance on REMS Modifications
The FDA has updated its guidance on changes to risk evaluation and mitigation strategies (REMS) with new details on submissions. Source: Drug GMP Report
Read MoreCDER Issues Guidance on Next Generation Sequencing Data for Antiviral Products
CDER released final guidance on submitting next generation nucleotide sequence (NGS) data to support resistance assessments for antiviral drugs. Source: Drug GMP Report
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