Most comments on the FDA’s draft guidance for reclassifying surgical staplers supported the move to reclassify devices from Class I to Class II but some cautioned that the rule could…
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…
The FDA has issued a final guidance on postmarketing safety reporting (PMSR) requirements for combination products. Source: The GMP Letter
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…
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
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…
The FDA cited six manufacturers for a variety of issues, including cross-contamination, complaint handling and quality system failures. Source: Drug GMP Report
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
The FDA has updated its guidance on changes to risk evaluation and mitigation strategies (REMS) with new details on submissions. Source: Drug GMP Report
CDER released final guidance on submitting next generation nucleotide sequence (NGS) data to support resistance assessments for antiviral drugs. Source: Drug GMP Report