Archive for December 2019
FDA Explains New 510(k) Pathway for Magnetic Resonance Coils
The FDA released draft guidance outlining the performance criteria sponsors of certain magnetic resonance coils should use to support substantial equivalence instead of a direct comparison. The guidance applies to sponsors who wish to submit a 510(k) application using the agency’s Safety and Performance Based Pathway. Source: The GMP Letter
Read MoreFDA Warns Device Manufacturer, Sterilizer in Texas
The FDA sent a warning letter to American Contract Systems for process validation violations at its Houston, Texas medical device manufacturing and sterilizing facility. Source: The GMP Letter
Read MoreEMA Group Flags Concerns Over Notified Bodies Assessing Companion Diagnostics
A European Medicines Agency expert group has raised concerns about notified bodies assessing companion diagnostics. Source: The GMP Letter
Read MoreFDA Clarifies Guidance on Export Certificate Denials
The FDA released final guidance for devicemakers laying out the information it provides when it denies export certificate requests and the steps firms should take to appeal rejections. Source: The GMP Letter
Read MoreCzech Firm Gets Non-Compliance Letter for Serious Deficiencies
A drugmaker in the Czech Republic was listed on the EudraGMDP inspection database for serious deficiencies at its Prague facility including the presence of mold and dead insects. Source: Drug GMP Report
Read More483 Roundup: Five Asian Companies Cited for Quality Deficiencies
The FDA rapped drugmakers in China, India and Japan after discovering good manufacturing practice violations at their facilities. Source: Drug GMP Report
Read MoreFDA Issues Guidance on Transdermal And Topical Drug Delivery Systems
The FDA outlined its current thinking on the information sponsors of transdermal and topical delivery systems (TDS) should include in their NDAs and ANDAs in a draft guidance. Source: Drug GMP Report
Read MoreWarning Letter Roundup: FDA Warns Six Firms for GMP, Other Violations
The FDA issued warning letters to six companies for violations ranging from data integrity deficiencies to selling unapproved products. Source: Drug GMP Report
Read MorePIC/S Drafts Recommendations on Risk-Based Change Management for Quality Systems
The Pharmaceutical Inspection Co-operation Scheme (PIC/S) released draft advice for GMP inspectors on evaluating risk-based changes to pharmaceutical quality systems (PQSs). Source: Drug GMP Report
Read MoreWHO Issues Guidance on Complying With Data Integrity Regulations
In a new draft guideline, the World Health Organization (WHO) offered recommendations on complying with data integrity, GMP documentation and recordkeeping requirements. Source: Drug GMP Report
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