Druggmpreport

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August 2019

No. 325

Headlines

Full Issue of Drug GMP Report in PDF Format

Download and view the full issue. Read More

FDA Data Chief Urges Drugmakers to Sign Up for Quality Metrics Programs

CDER’s associate director for data analysis, Karthik Iyer, urged drugmakers to sign up for the agency’s quality metrics feedback program and the quality metrics site visit program, in a presentation at the Drug Information Association’s annual meeting in San Diego. Read More

CDER 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. Read More

FDA 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. Read More

FDA 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. Read More

483 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. Read More

WHO 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. Read More

FDA 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. Read More